Description:
Master protocol for cell therapy, Phase 1 proof-of-concept studies., in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
Master protocol for cell therapy, Phase 1 proof-of-concept studies., in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
Recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
CART-ddBCMA | ARM 1 |
ARM 1 is a, non-randomized, open label, multi-site Phase 1 study. CART-ddBCMA is a BCMA directed CAR with a non-scFv binding domain that has been deimmunized.
Name | Type | Description | Interventions |
---|---|---|---|
ARM 1 | Experimental | Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma |
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Inclusion Criteria: - Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease - Documented measurable disease - Adequate organ function - Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1 Exclusion Criteria: - Plasma Cell Leukemia or History of Plasma Cell Leukemia - Patients with a history of severe hypersensitivity to DMSO should be excluded - Contraindication to fludarabine or cyclophosphamide - Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities - Active central nervous system disease involvement by malignancy or active CNS pathology
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Incidence of treatment-emergent adverse events (TEAEs), including DLT(s) |
Time Frame: | 24 months |
Safety Issue: | |
Description: |
Measure: | Best overall response (BOR) and ORR by IMWG Consensus Criteria |
Time Frame: | 24 months |
Safety Issue: | |
Description: |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Arcellx, Inc. |
May 20, 2021