Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

• ClinicalTrials.gov Identifier: NCT03331198
• Recruitment Status: Recruiting
• First Posted: November 6, 2017
• Last Update Posted: May 2, 2024
• Sponsor: Juno Therapeutics, a Subsidiary of Celgene
• Information provided by (Responsible Party): Juno Therapeutics, a Subsidiary of Celgene

Study Description

Brief Summary:

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

Condition or disease	Intervention/treatment	Phase
Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Small Lymphocytic	Biological: JCAR017 (lisocabtagene maraleucel); Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib; Biological: JCAR017 (lisocabtagene maraleucel) + venetoclax	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 209 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase 1: subjects will be assigned to receive JCAR017, or JCAR017 + ibrutinib Phase 2: subjects will be assigned to receive JCAR017 at the recommended dose
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
• Actual Study Start Date: November 27, 2017
• Estimated Primary Completion Date: November 26, 2027
• Estimated Study Completion Date: November 26, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Phase 1 JCAR017 monotherapy; Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)	Biological: JCAR017 (lisocabtagene maraleucel); Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 1 JCAR017 + ibrutinib; Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib	Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib; Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 2 JCAR017 monotherapy; Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm	Biological: JCAR017 (lisocabtagene maraleucel); Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 1 JCAR017 + venetoclax; Subjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.	Biological: JCAR017 (lisocabtagene maraleucel) + venetoclax; Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.

Outcome Measures

Primary Outcome Measures :

1. Phase 1 JCAR017 monotherapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing adverse events
2. Phase 1 JCAR017 monotherapy arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing laboratory abnormalities
3. Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing adverse events
4. Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing laboratory abnormalities
5. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm [ Time Frame: Through post treatment up to Month 48 ]
   Proportion of subjects who have CR after treatment with JCAR017 + ibrutinib using iwCLL 2018 guidelines
6. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing adverse events
7. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing laboratory abnormalities
8. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm [ Time Frame: Through post treatment up to Month 48 ]
   Proportion of subjects who have CR after treatment with JCAR017 + venetoclax using iwCLL 2018 guidelines
9. Phase 2 JCAR017 monotherapy expansion arm [ Time Frame: Through post treatment up to Month 48 ]
   Proportion of subjects who have CR after treatment with JCAR017 using iwCLL 2018 guidelines

Secondary Outcome Measures :

1. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing adverse events
2. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects experiencing laboratory abnormalities
3. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: ORR [ Time Frame: Up to 48 months post treatment ]
   Defined as the rate of CR (including CRi)
4. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD negative response rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects who achieve MRD CR
5. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD-negative CR rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
   Proportion of subjects who achieve MRD CR
6. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR) [ Time Frame: Up to 48 months post treatment ]
   Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
7. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of complete response (DoCR) [ Time Frame: Up to 48 months post treatment ]
   Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
8. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to response (TTR) [ Time Frame: Up to 48 months post treatment ]
   Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
9. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to complete response (TTCR) [ Time Frame: Up to 48 months post treatment ]
   Defined as the interval from JCAR017 infusion to the first documentation of CR
10. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: PFS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
11. Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: OS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the date of death due to any cause
12. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: adverse events [ Time Frame: Up to 48 months post treatment ]
    Proportion of subject experiencing adverse events
13. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects experiencing laboratory abnormalities
14. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: ORR [ Time Frame: Through post treatment Day 90 ]
    Defined as the rate of CR (including CRi)
15. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: MRD-negative response rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects who achieve MRD CR
16. Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: MRD-negative CR rate in peripheral blood [ Time Frame: Through post treatment Day 90 ]
    Proportion of subjects who achieve MRD CR
17. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of response (DOR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
18. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of complete response (DoCR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
19. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to response (TTR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
20. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to complete response (TTCR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the interval from JCAR017 infusion to the first documentation of CR
21. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: PFS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
22. Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: OS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the date of death due to any cause
23. Phase 2 JCAR017 Monotherapy Expansion Arm: adverse events [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects experiencing adverse events
24. Phase 2 JCAR017 Monotherapy Expansion Arm: laboratory abnormalities [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects experiencing laboratory abnormalities
25. Phase 2 JCAR017 Monotherapy Expansion Arm: ORR [ Time Frame: Up to 48 months post treatment ]
    Defined as the rate of CR (including CRi)
26. Phase 2 JCAR017 Monotherapy Expansion Arm: MRD negative response rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects who achieve MRD CR
27. Phase 2 JCAR017 Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood [ Time Frame: Up to 48 months post treatment ]
    Proportion of subjects who achieve MRD CR
28. Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of response (DOR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
29. Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of complete response (DoCR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
30. Phase 2 JCAR017 Monotherapy Expansion Arm: Time to response (TTR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
31. Phase 2 JCAR017 Monotherapy Expansion Arm: Time to complete response (TTCR) [ Time Frame: Up to 48 months post treatment ]
    Defined as the interval from JCAR017 infusion to the first documentation of CR
32. Phase 2 JCAR017 Monotherapy Expansion Arm: PFS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
33. Phase 2 JCAR017 Monotherapy Expansion Arm: OS [ Time Frame: Up to 48 months post treatment ]
    Defined as the time from JCAR017 infusion to the date of death due to any cause
34. Phase 2 JCAR017 Monotherapy Expansion Arm: Health-related quality of life (HRQoL) questionnaire [ Time Frame: Up to 48 months post treatment ]
    Change from baseline in HRQoL assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
35. Phase 2 JCAR017 Monotherapy Expansion Arm: HRQoL questionnaire [ Time Frame: Up to 48 months post treatment ]
    Change from baseline in HRQoL assessed using the EORTC chronic lymphocytic leukemia (CLL)-specific module QLQ-CLL-17
36. Phase 2 JCAR017 Monotherapy Expansion Arm: Health economics and outcomes research (HEOR) questionnaire [ Time Frame: Up to 48 months post treatment ]
    Change from baseline in measurement of health utility values using EuroQol instrument EQ-5D-5L
37. Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire [ Time Frame: Up to 48 months post treatment ]
    Proportion of participants with intensive care unit (ICU) inpatient days
38. Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire [ Time Frame: Up to 48 months post treatment ]
    Proportion of participants with non-ICU inpatient days

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diagnosis of:

  1. CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or
  2. SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL)
• Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.

• Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received previous treatment as follows:

  1. Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
  2. Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.

• Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:

  1. be receiving ibrutinib and progressing at the time of study enrollment
  2. be receiving ibrutinib for at least 6 months with a response less than complete response/remission (CR) and have high-risk features as defined in inclusion criterion 5a
  3. have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
  4. have previously received ibrutinib and have no contraindications to restarting ibrutinib
• Eastern Cooperative Oncology Group performance status of ≤ 1
• Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy

• Adequate organ function, defined as:

  1. Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance > 30 mL/min
  2. Alanine aminotransferase ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
  3. Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air
  4. Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility
• Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
• If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
• Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax

• Subjects in venetoclax + JCAR017 combination cohort must:

  1. have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi
  2. be venetoclax naive (required for dose expansion) or
  3. if prior venetoclax (only for dose escalation)
  4. have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation
• subjects in the venetoclax + JCAR017 combination must have hemoglobin >=9 g/dL, absolute neutrophil count >=500mm3 and platelets>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
• must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry

Exclusion Criteria:

• Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
• History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)
• Subjects with Richter's transformation
• Prior treatment with any gene therapy product
• Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection
• Systemic fungal, bacterial, viral, or other infection that is not controlled
• Presence of acute or extensive chronic graft versus host disease (GVHD)
• History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
• History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis
• Pregnant or nursing (lactating) women

• Use of any of the following medications or treatments within the noted time prior to leukapheresis:

  1. Alemtuzumab within 6 months prior to leukapheresis
  2. Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis
  3. Cladribine within 3 months prior to leukapheresis
  4. Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis
  5. Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis
  6. Fludarabine within 4 weeks prior to leukapheresis
  7. GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α [TNFα], anti-interleukin-6 [IL-6], or anti-interleukin-6 receptor [IL 6R]) within 4 weeks prior to leukapheresis
  8. Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis
  9. Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
  10. Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
  11. Venetoclax within 4 days prior to leukapheresis
  12. Idelalisib or duvelisib within 2 days prior to leukapheresis
  13. Lenalidomide within 1 day prior to leukapheresis
  14. Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
• Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol
• Progressive vascular tumor invasion, thrombosis, or embolism
• Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation
• Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.
• Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation
• For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com; 855-907-3286; Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

United States, Alabama

Local Institution - 0006; Active, not recruiting

Birmingham, Alabama, United States, 35294

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Contact: Tiffany Hill 205-996-8023 tiffanydhill@uabmc.edu

Contact: Danielle Mussey 205-996-1795 dmussey@uabmc.edu

Principal Investigator: Amitkumar Mehta, MD

United States, Arizona

Banner MD Anderson Cancer Center; Recruiting

Gilbert, Arizona, United States, 85234

Contact: Brenda Noggy 480-256-3425 brenda.noggy@bannerhealth.com

Principal Investigator: Rajneesh Nath, MD

Local Institution - 0043; Active, not recruiting

Gilbert, Arizona, United States, 85234

United States, California

Local Institution - 0007; Active, not recruiting

Duarte, California, United States, 91010-301

City of Hope; Recruiting

Duarte, California, United States, 91010

Contact: Hormoz Mirshkarlo, MD 626-256-4673 ext 69074 hmirshkarlo@coh.org

Principal Investigator: Tanya Siddiqi, MD

Local Institution - 0025; Active, not recruiting

La Jolla, California, United States, 92093

UC San Diego Moores Cancer Center; Recruiting

La Jolla, California, United States, 92093

Contact: Krisma C Montalvo 858-246-0386 kcmontalvo@ucsd.edu

Contact: Kimberly Aguilar 858-534-5201 k1aguilar@ucsd.edu

Principal Investigator: Thomas J Kipps, MD, PhD

Local Institution - 0059; Active, not recruiting

Los Angeles, California, United States, 90095

University of California, Los Angeles; Recruiting

Los Angeles, California, United States, 90095

Contact: Joy Valadez 310-794-6500 jvaladez@mednet.ucla.edu

Contact: Anna Crosetti 310-794-6500 acrosetti@mednet.ucla.edu

Principal Investigator: Herbert Eradat, MD, MS

Local Institution - 0010; Active, not recruiting

San Francisco, California, United States, 94143

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94143

Contact: Andrew Chon 415-476-2351 andrew.chon@ucsf.edu

Principal Investigator: Lawrence Kaplan, MD

United States, District of Columbia

Georgetown University Medical Center; Recruiting

Washington, District of Columbia, United States, 20007

Contact: Pari Ramzi 202-784-0038 ramzip1@georgetown.edu

Principal Investigator: Pashna Munshi, MD

Local Institution - 0085; Completed

Washington, District of Columbia, United States, 20007

United States, Florida

Local Institution - 0080; Active, not recruiting

Jacksonville, Florida, United States, 32224

Mayo Clinic; Recruiting

Jacksonville, Florida, United States, 32224

Contact: Mohamed Kharfan-Dabaja, MD 904-953-2000 kharfandabaja.mohamed@mayo.edu

Contact: Teresa Banda 214-820-1660 teresa.banda@bswhealth.org

Principal Investigator: Mohamed Kharfan-Dabaja, MD

United States, Georgia

Local Institution - 0019; Active, not recruiting

Atlanta, Georgia, United States, 30342

The Blood and Marrow Transplant Group of Georgia (BMTGA); Recruiting

Atlanta, Georgia, United States, 30342

Contact: Scott R Solomon, MD 404-255-1930 ssolomon@bmtga.com

Contact: Stacey Brown 404-780-7965 Stacey.brown@northside.com

Principal Investigator: Scott R Solomon, MD

United States, Illinois

Local Institution - 0003; Active, not recruiting

Chicago, Illinois, United States, 60611

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: Study Coordinator 312-695-1301 cancertrials@northwestern.edu

Contact: Arezou Ireta 312-695-8169 a-ireta@northwestern.edu

Principal Investigator: Shuo Ma, MD, PhD

Local Institution - 0016; Active, not recruiting

Chicago, Illinois, United States, 60637

University of Chicago Medical Center; Recruiting

Chicago, Illinois, United States, 60637

Contact: Sadi Dixon, RN 773-702-2070 sdixon2@medicine.bsd.uchicago.edu

Contact: Elaine Hoekstra 773-884-8528 ehoekstra1@medicine.bsd.uchicago.edu

Principal Investigator: Peter Riedell, MD

United States, Massachusetts

Local Institution - 0005; Active, not recruiting

Boston, Massachusetts, United States, 02114

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Jacob D Soumerai, MD 617-724-4000 jsoumerai@mgh.harvard.edu

Principal Investigator: Jacob D Soumerai, MD

Beth Israel Deaconess Medical Center; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Emma Logan, RN 617-667-5984 eklogan@bidmc.harvard.edu

Contact: Pavania Elavalakanar 617-667-1903 pelavala@bidmc.harvard.edu

Principal Investigator: Jon Arnason, MD

Local Institution - 0015; Active, not recruiting

Boston, Massachusetts, United States, 02215

United States, Michigan

University of Michigan Comprehensive Cancer Center; Recruiting

Ann Arbor, Michigan, United States, 48109-5362

Contact: U of M Cancer Answerline 800-865-1125

Principal Investigator: Monalisa Ghosh, MD

Local Institution - 0084; Active, not recruiting

Ann Arbor, Michigan, United States, 48109

Barbara Ann Karmanos Cancer Institute; Recruiting

Detroit, Michigan, United States, 48201

Contact: Joo En Kim, MPH 313-576-8030 kimjo@karmanos.org

Principal Investigator: Abhinav Deol, MD

Local Institution - 0062; Active, not recruiting

Detroit, Michigan, United States, 48201

United States, Minnesota

Local Institution - 0054; Active, not recruiting

Rochester, Minnesota, United States, 55905

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Clinical Trials Referral Office 855-776-0015

Contact: Gabrielle Bouska 507-538-0586 bouska.gabrielle@mayo.edu

Principal Investigator: Saad Kenderian, MB, ChB

United States, Nebraska

Local Institution - 0008; Active, not recruiting

Omaha, Nebraska, United States, 68198

University of Nebraska Medical Center; Recruiting

Omaha, Nebraska, United States, 68198

Contact: Gail A Paulsen 402-559-3853 gpaulsen@unmc.edu

Contact: Lindsay Hicks 402-559-6044 lindsay.hick@unmc.edu

Principal Investigator: Julie Vose, MD

United States, New Jersey

Local Institution - 0038; Active, not recruiting

Hackensack, New Jersey, United States, 07601-2191

Hackensack University Medical Center; Recruiting

Hackensack, New Jersey, United States, 07601

Contact: Kara Yannotti, RNC 551-996-5168 Kara.Yannotti@Hackensackmeridian.org

Principal Investigator: Tatyana Feldman, MD

Local Institution - 0077; Completed

New Brunswick, New Jersey, United States, 08903

Rutgers Cancer Institute of New Jersey; Recruiting

New Brunswick, New Jersey, United States, 08903

Contact: Oona Harrigan 732-235-5609 oh77@cinj.rutgers.edu

Contact: Roger Strair, MD, PhD 732-235-4523 strairrk@cinj.rutgers.edu

Principal Investigator: Roger Strair, MD, PhD

United States, New York

Local Institution - 0035; Active, not recruiting

New York, New York, United States, 10021

Columbia University Medical Center; Withdrawn

New York, New York, United States, 10032

Local Institution - 0026; Completed

New York, New York, United States, 10032

Weill Cornell Medical College; Recruiting

New York, New York, United States, 10065

Contact: June Greenburg 212-746-2651 jdg2002@med.cornell.edu

Contact: Koen Van Besien 212-746-2048 kov9001@med.cornell.edu

Principal Investigator: Koen Van Besien, MD, PhD

United States, North Carolina

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27705

Contact: Danielle Brander, Site 0030 919-684-8964

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27710

Contact: Rachel Stowe 919-681-4769 rachel.stowe@duke.edu

Contact: Danielle M Brander, MD 919-684-8964 danielle.brander@duke.edu

Principal Investigator: Danielle M Brander, MD

United States, Ohio

University Hospitals Seidman Cancer Center (Case Western); Recruiting

Cleveland, Ohio, United States, 44106-5061

Contact: Paolo Caimi, MD 216-844-3951 Paolo.Caimi@UHhospitals.org

Contact: Yeritza Hernandez-Collazo, MS 216-844-3951 Yeritza.Hernandez-Collazo@UHhospitals.org

Principal Investigator: Paolo Caimi, MD

Local Institution - 0078; Active, not recruiting

Cleveland, Ohio, United States, 44106

United States, Oklahoma

Local Institution - 0082; Active, not recruiting

Oklahoma City, Oklahoma, United States, 73104

University of Oklahoma Health Sciences Center (Stephenson Cancer Center); Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contact: Adam Asch, MD 405-271-8000 adam-asch@ouhsc.edu

Principal Investigator: Adam Asch, MD

United States, Oregon

Local Institution - 0098; Active, not recruiting

Eugene, Oregon, United States, 97401

United States, Pennsylvania

Local Institution - 0088; Active, not recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Pennsylvania Perelman Center for Advanced Medicine; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Stephen Schuster, MD 215-662-6065 stephen.schuster@uphs.upenn.edu

Principal Investigator: Stephen Schuster, MD

Local Institution - 0032; Active, not recruiting

Philadelphia, Pennsylvania, United States, 19107

Thomas Jefferson University; Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contact: Allison Scott 215-955-5903 allison.scott@jefferson.edu

Principal Investigator: Matthew Carabasi, MD

Local Institution - 0029; Active, not recruiting

Pittsburgh, Pennsylvania, United States, 15232

UPMC Hillman Cancer Center; Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contact: Linda Fukas

Contact 412-623-6037 fukaslj@upmc.edu

Principal Investigator: Kathleen Dorritie, MD

United States, Texas

Baylor University Medical Center; Recruiting

Dallas, Texas, United States, 75246

Contact: Houston E Holmes III, MD, FACP 214-370-1077

Principal Investigator: Houston E Holmes III, MD, FACP

Local Institution - 0083; Completed

Dallas, Texas, United States, 75390

University of Texas Southwestern Medical Center; Recruiting

Dallas, Texas, United States, 75390

Contact: Courtney Saltarski 214-648-7030 courtney.saltarski@utsouthwestern.edu

Contact: Farrukh Awan, MD 214-648-4077 farrukh.awan@utsouthwestern.edu

Principal Investigator: Farrukh Awan, MD

Local Institution - 0079; Completed

Dallas, Texas, United States, 75426

Local Institution - 0002; Active, not recruiting

Houston, Texas, United States, 77030

The University of Texas MD Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Contact: William G Wierda, MD, PhD 713-792-7026 wwierda@mdanderson.org

Principal Investigator: William G Wierda, MD, PhD

United States, Utah

Huntsman Cancer Institute; Recruiting

Salt Lake City, Utah, United States, 84112

Contact: Kolleen Hicks, BS 801-587-7604 Kolleen.Hicks@hci.utah.edu

Principal Investigator: Deborah Stephens, DO

Local Institution - 0028; Active, not recruiting

Salt Lake City, Utah, United States, 84112

United States, Virginia

Local Institution - 0087; Completed

Richmond, Virginia, United States, 23298

Virginia Commonwealth University; Withdrawn

Richmond, Virginia, United States, 23298

United States, Washington

Fred Hutchinson Cancer Research Center; Recruiting

Seattle, Washington, United States, 98109

Contact: SCCA Immunotherapy Trials Intake 206-606-4668 immunotherapy@seattlecca.org

Principal Investigator: David Maloney, MD, PhD

Local Institution - 0018; Active, not recruiting

Seattle, Washington, United States, 98109

United States, Wisconsin

Local Institution - 0055; Active, not recruiting

Milwaukee, Wisconsin, United States, 53226

Medical College of Wisconsin; Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Nirav Shah, MD 414-805-4600 nishah@mcw.edu

Principal Investigator: Nirav Shah, MD

Sponsors and Collaborators

Juno Therapeutics, a Subsidiary of Celgene

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information 

BMS Clinical Trial Patient Recruiting 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21.

Siddiqi T, Soumerai JD, Dorritie KA, Stephens DM, Riedell PA, Arnason J, Kipps TJ, Gillenwater HH, Gong L, Yang L, Ogasawara K, Thorpe J, Wierda WG. Phase 1 TRANSCEND CLL 004 study of lisocabtagene maraleucel in patients with relapsed/refractory CLL or SLL. Blood. 2022 Mar 24;139(12):1794-1806. doi: 10.1182/blood.2021011895.

• Responsible Party: Juno Therapeutics, a Subsidiary of Celgene
• ClinicalTrials.gov Identifier: NCT03331198
• Other Study ID Numbers: 017004; TRANSCEND-CLL-004 ( Other Identifier: Juno Therapeutics, Inc. )
• First Posted: November 6, 2017
• Last Update Posted: May 2, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juno Therapeutics, a Subsidiary of Celgene:

TRANSCEND_CLL_004

Additional relevant MeSH terms:

Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Venetoclax; Ibrutinib; Antineoplastic Agents; Tyrosine Kinase Inhibitors; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action