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 |
|
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