Trials / Completed
CompletedNCT04450069
CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Calibr, a division of Scripps Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 differentiation antigen 19) antibody (SWI019, the switch, a biologic). In combination, SWI019 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.
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
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | CLBR001 and SWI019 | Investigational immunotherapy for B cell malignancies |
Timeline
- Start date
- 2020-08-14
- Primary completion
- 2024-05-06
- Completion
- 2024-05-06
- First posted
- 2020-06-29
- Last updated
- 2024-08-20
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04450069. Inclusion in this directory is not an endorsement.