CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
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ClinicalTrials.gov Identifier: NCT04450069 |
Recruitment Status :
Active, not recruiting
First Posted : June 29, 2020
Last Update Posted : January 24, 2024
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Condition or disease | Intervention/treatment | Phase |
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Relapsed/Refractory B-cell Lymphomas Diffuse Large B Cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Chronic Lymphocytic Leukemia (CLL) Marginal Zone Lymphoma (MZL) Mantle Cell Lymphoma Small Lymphocytic Lymphoma (SLL) Primary Mediastinal Large B Cell Lymphoma Transformed Follicular Lymphoma Waldenstrom Macroglobulinemia Lymphoplasmacytic Lymphoma Burkitt Lymphoma | Combination Product: CLBR001 and SWI019 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the Combination of CLBR001 and SWI019 in Patients With Relapsed/Refractory B-cell Malignancies |
Actual Study Start Date : | August 14, 2020 |
Estimated Primary Completion Date : | April 2024 |
Estimated Study Completion Date : | June 2024 |
Arm | Intervention/treatment |
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Experimental: Dose Escalation
CLBR001 + SWI019 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD)
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Combination Product: CLBR001 and SWI019
Investigational immunotherapy for B cell malignancies |
- Frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events [ Time Frame: 35 days ]To determine the frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events
- Number of first cycle dose limiting toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: up to 1 year ]Based on the number of first cycle dose limiting toxicities (DLT) as assessed by CTCAE to determine maximum tolerated dose (MTD)
- Maximum drug concentration (Cmax) of SWI019 [ Time Frame: up to Day 35 ]To determine the maximum concentration of SWI019 in a patient's peripheral blood
- Area under the curve (AUC) of SWI019 [ Time Frame: up to Day 35 ]To quantify the cumulative amount of SWI019 in a patient's peripheral blood over time
- Time to reach Cmax (Tmax) of SWI019 [ Time Frame: up to Day 35 ]To identify the time point when the concentration of SWI019 reaches maximum in a patient's peripheral blood
- Clearance (CL) of SWI019 [ Time Frame: up to Day 35 ]To determine the clearance factor of SWI019 in a patient's peripheral blood
- Apparent elimination half-life (t1/2) of SWI019 [ Time Frame: up to Day 35 ]To identify the time point when the concentration of SWI019 reaches half of maximum in a patient's peripheral blood
- Quantification of CLBR001 cells in peripheral blood [ Time Frame: up to 1 year ]To quantify CLBR001 in a patient's peripheral blood at different time points
- Phenotype of CLBR001 in peripheral blood and/or tumor/bone marrow biopsies [ Time Frame: up to 1 year ]To evaluate the phenotype of CLBR001 in a patient's peripheral blood at different time points by flow cytometry
- Immunogenic response to CLBR001 [ Time Frame: up to 1 year ]To evaluate the anti-drug antibodies in response to CLBR001 administration in a patient's peripheral blood
- Immunogenic response to SWI019 [ Time Frame: up to 1 year ]To evaluate the anti-drug antibodies in response to SWI019 administration in a patient's peripheral blood
- Serum cytokine concentrations [ Time Frame: up to 1 year ]To measure the cytokine levels (e.g. TNFa, IL-6, IL-1, IL-2, etc.) in a patient's peripheral blood at different time points
- Overall (best) objective response by the Response Evaluation Criteria in Lymphoma (RECIL) and Lugano criteria [ Time Frame: up to 1 year ]To determine the overall (best) objective anti-cancer response by RECIL and Lugano criteria
- Duration of response (DOR) [ Time Frame: up to 1 year ]To evaluate the duration of anti-cancer response after CLBR001 and SWI019 administration
- Progression free survival (PFS) [ Time Frame: up to 1 year ]To evaluate the duration of patient's progression-free survival
- Overall survival (OS) [ Time Frame: up to 1 year ]To evaluate the overall duration of patient's survival
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with relapsed / refractory previously treated B cell malignancies (according to the World Health Organization classification; 2017)
- Patients must have received adequate prior therapy including at least two lines of prior therapies including anthracycline or bendamustine-containing chemotherapy, anti-CD20 (cluster of differentiation antigen 20) therapies and/or Brutton's tyrosine kinase (BTK) inhibitors
- Patients treated with prior CD19 targeted molecules (e.g., Blincyto) must have confirmed CD19+ disease
- Patients must be ineligible for allogeneic stem cell transplant (SCT)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Estimated life expectancy of ≥ 12 weeks from the first day of SWI019 dose administered
- Willing to undergo pre- and post-treatment core needle biopsy
- Adequate hematological, renal, pulmonary, cardiac, and liver function
- Resolved adverse events of any prior therapy to either baseline or CTCAE Grade ≤1
- Women of childbearing potential, a negative pregnancy test and must agree to practice effective birth control
- Men sexually active with female partners of child bearing potential must agree to practice effective contraception
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other procedures
Exclusion Criteria:
- Patients diagnosed with certain disease histologies including pediatric lymphomas/leukemias, monoclonal gammopathy of undetermined significance (MGUS), T-cell histiocyte large B cell lymphoma
- Pregnant or lactating women
- Active bacterial, viral, and fungal infections
- History of allogeneic stem cell transplantation
- Treatment with any prior lentiviral or retroviral based CAR-T
- Patients receiving live (attenuated) vaccines within 4 weeks of screening visit or need for live vaccine on study
- Patients with known active central nervous system (CNS) disease. Patients with prior CNS disease that has been effectively treated may be eligible
- History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction, unstable angina or other significant cardiac disease within 6 months of screening
- Involvement of cardiac tissue by lymphoma
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP)
- HIV-1 and HIV-2 antibody positive patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450069
United States, California | |
City of Hope National Medical Center | |
Duarte, California, United States, 91010 | |
University of California at San Diego | |
San Diego, California, United States, 92093 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Minnesota | |
Masonic Cancer Center, University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Weill Cornell Medical College - New York Presbyterian Hospital | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Wake Forest Baptist Health | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Tennessee | |
Sarah Cannon Research Institute - Tennessee Oncology | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Sarah Cannon Research Institute - Texas Transplant Institute | |
San Antonio, Texas, United States, 78229 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Calibr, a division of Scripps Research |
ClinicalTrials.gov Identifier: | NCT04450069 |
Other Study ID Numbers: |
CBR-sCAR19-3001 |
First Posted: | June 29, 2020 Key Record Dates |
Last Update Posted: | January 24, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CAR-T Cell Therapy Switchable CAR-T Cell Autologous Cell Therapy CD19 Positive Disease |
CD19 CAR-T Cell Blood Cancer Hematological malignancy Neoplasms |
Burkitt Lymphoma Lymphoma Neoplasms Lymphoma, Follicular Lymphoma, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
Leukemia, Lymphoid Leukemia Hematologic Diseases Leukemia, B-Cell Chronic Disease Disease Attributes Pathologic Processes Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Neoplasms, Plasma Cell Hemostatic Disorders |