Status:
COMPLETED
CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
Lead Sponsor:
Calibr, a division of Scripps Research
Conditions:
Relapsed/Refractory B-cell Lymphomas
Diffuse Large B Cell Lymphoma (DLBCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
CLBR001 + SWI019 is an combination investigational immunotherapy being evaluated as a potential treatment for patients diagnosed with B cell malignancies who are refractory or unresponsive to salvage ...
Detailed Description
CLBR001 + SWI019 is a two-component therapy comprising an autologous chimeric antigen receptor T (CAR-T) cell product (CLBR001, the switchable CAR-T cell (sCAR-T)) and an anti-CD19 (cluster of differe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04450069
Start Date
August 14 2020
End Date
May 6 2024
Last Update
August 20 2024
Active Locations (8)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of California at San Diego
San Diego, California, United States, 92093
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455