Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma
- Interventional
- Recruiting
- NCT04155749
Contact Information
Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including 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.
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.
ARM 2 is a non-randomized, open label, multi-site Phase 1 study. Using the bivalent BCMA-Specific Adapter (SPRX001) and Universal CAR-Modified T cell (ARC-T Cells)
ARM 2 is a non-randomized, open label, multi-site Phase 1 study. Using the bivalent BCMA-Specific Adapter (SPRX001) and Universal CAR-Modified T cell (ARC-T Cells)
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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
- 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