CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
Completed · Phase 1
Conditions studied: 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
In brief
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 therapy or who cannot be considered for or have progressed after autologous hematopoietic cell transplantation. This first-in-human study will assess the safety and tolerability of CLBR001 + SWI019 and is designed to determine the maximum tolerated dose (MTD) or optimal SWI019 dose (OSD). Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019. The study will also assess the pharmacokinetics and pharmacodynamics of CLBR001 + SWI019.
Key facts
- Study ID
- NCT04450069
- Run by
- Calibr, a division of Scripps Research
- People needed
- 18
- Starts
- 2020-08-14
- Expected to finish
- 2024-05-06
- Last updated by the study team
- 2024-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- University of California at San Diego — San Diego, California, United States
- University of Chicago — Chicago, Illinois, United States
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
- Weill Cornell Medical College - New York Presbyterian Hospital — New York, New York, United States
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
- Sarah Cannon Research Institute - Tennessee Oncology — Nashville, Tennessee, United States
- Sarah Cannon Research Institute - Texas Transplant Institute — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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