CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
NCT04450069 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-08-20
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 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.
Conditions
- 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
Interventions
- COMBINATION_PRODUCT
-
CLBR001 and SWI019
Investigational immunotherapy for B cell malignancies
Sponsors & Collaborators
-
Calibr, a division of Scripps Research
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-14
- Primary Completion
- 2024-05-06
- Completion
- 2024-05-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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