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DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05680922
Recruitment Status : Recruiting
First Posted : January 11, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Legend Biotech USA Inc

Study Description
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Brief Summary:
This is a phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells in subjects with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Extensive Stage Large Cell Neuroendocrine Carcinoma of the Lung Biological: LB2102 Phase 1

Detailed Description:
This is a phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells in subjects with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer. The study comprises a dose-escalation component (Part A) and a cohort expansion component (Part B). Up to 41 subjects will be treated in this study. Part A will enroll and treat up to 24 subjects and Part B will be conducted after the recommended dose for expansion (RDE) has been identified in Part A and enroll up to 17 subjects. Both parts of this trial will include a Screening Period, a Pretreatment Period, a Treatment Period, a Follow-Up Period, and a Post-Progression Follow-Up Period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First in Human Dose Escalation and Cohort Expansion Study of DLL3-directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer
Actual Study Start Date : July 26, 2023
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : March 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental LB2102
DLL3-Directed Chimeric Antigen Receptor T-cells (CAR T)
 Biological: LB2102
DLL3 directed autologous Chimeric Antigen Receptor T-cells


Outcome Measures
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Primary Outcome Measures :
  1. To characterize the safety and tolerability of LB2102 and determine recommended dose for expansion (RDE) [ Time Frame: 28 days ]
    Multiple doses will be tested to establish a recommended dose

  2. To further characterize the safety and tolerability of LB2102 with the RDE identified in the dose-escalation and determine the recommended Phase 2 dose (RP2D) [ Time Frame: 90 days ]
    Treatment of additional patients at the recommended dose as identified in the initial dose escalation part of the study


Secondary Outcome Measures :
  1. To evaluate the preliminary efficacy of LB2102 [ Time Frame: Through study completion, a minimum of 2 years ]
    Measured by Response Evaluation Criteria In Solid Tumors (RECIST)

  2. To characterize the pharmacokinetics of LB2102 in blood [ Time Frame: Through study completion, a minimum of 2 years ]
    CAR-positive T cell counts in cells/microliter (μL) blood

  3. To evaluate the immunogenicity of LB2102 [ Time Frame: Through study completion, a minimum of 2 years ]
    Number of subjects with presence of anti-LB2102 antibodies


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

Inclusion Criteria:

  • Be at least 18 years of age and willing and able to provide a written informed consent
  • Have histologically/cytologically confirmed unresectable small cell lung carcinoma (SCLC), large cell neuroendocrine lung carcinoma (LCNEC), combined SCLC, or combined LCNEC as per WHO 2021 criteria
  • Subjects who have at least one prior line of standard treatment, and have progressed after or have had an insufficient response, and for whom standard treatment is intolerable, unlikely to confer significant clinical benefit, is no longer effective, or the subject declines further standard treatment
  • Have available formalin-fixed, paraffin-embedded tumor specimen in a tissue block or unstained serial slides accompanied by an associated pathology report prior to enrollment. Archival or fresh biopsy tissue is required
  • Presence of ≥ 1 radiologically measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 4 months
  • Have adequate organ function
  • Women of childbearing potential must have a negative pregnancy test at screening using a highly sensitive serum pregnancy test (β-human chorionic gonadotropin [β-hCG])
  • All subjects must agree to practice a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) from the time of signing the informed consent form (ICF) to 1 year after receiving a LB2102 infusion
  • Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, until at least 1 year after receiving a LB2102 infusion
  • Must have adequate leukapheresis material of non-mobilized cells available for manufacturing

Exclusion Criteria:

  • Prior treatment with cellular immunotherapy (e.g., CAR-T) or gene therapy product
  • Prior treatment with DLL3-targeted therapy
  • Prior history of checkpoint inhibitor associated pneumonitis
  • Clinically significant ascites, pleural or peritoneal effusions
  • Primary acquired or inherited immunodeficiency syndromes
  • Known leptomeningeal metastases
  • Active or symptomatic brain metastasis. Subjects with treated brain metastasis are eligible provided additional requirements are met per protocol.
  • Active autoimmune disease receiving immunomodulatory treatments (e.g., cyclosporine or high dose systemic steroids)
  • Impaired cardiac function or clinically significant cardiac disease not controlled by medications
  • Previous or concurrent malignancy, excluding certain exceptions
  • Serious and /or uncontrolled medical condition that, in the Investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol
  • Subjects with known active infection with HIV, hepatitis B, and/or hepatitis C virus (HBV/HCV) are not eligible unless additional protocol requirements are met.
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to LB2102 excipients, such as dimethyl sulfoxide; or to fludarabine, cyclophosphamide, or tocilizumab
  • Ongoing toxicity of organ functions from previous anticancer therapy that has not resolved to Grade 1 or less, except for alopecia
  • Major surgery within 4 weeks prior to apheresis, or planned within 4 weeks after LB2102 administration
  • Pregnant or breast-feeding
  • Plans to become pregnant or breastfeed, or father a child within 1 year after receiving a LB2102 infusion
  • Previous history of allogeneic hematopoietic stem cell transplantation (HSCT), organ transplant, or in preparation for organ transplant
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05680922


Contacts
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Contact: Legend Biotech USA 17323175050 medical.information@legendbiotech.com

Locations
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United States, Florida
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Alberto Chiappori, MD         
United States, Kentucky
University of Kentucky - Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Zhonglin Hao, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob Sands, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10017
Contact: Adam Schoenfeld, MD         
Sponsors and Collaborators
Legend Biotech USA Inc
More Information
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Responsible Party: Legend Biotech USA Inc
ClinicalTrials.gov Identifier: NCT05680922    
Other Study ID Numbers: LB2102-1001
First Posted: January 11, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue