Trial | NCT04155749  Report issue

Title

Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    CART-ddBCMA ...

  • Study Participants

    65
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)
Study Started
Nov 18
2019
Primary Completion
Aug 31
2024
Anticipated
Study Completion
Nov 01
2035
Anticipated
Last Update
Jul 12
2023

Drug CART-ddBCMA

Chimeric Antigen Receptor T cells

Drug ARC-T Plus Anti-BCMA SparX

Chimeric Antigen Receptor T cells plus SparX protein

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

Arm 2 Experimental

Phase 1 Study of Bivalent BCMA-Specific Adapter (SPRX001) and Universal CAR-Modified T cell (ARC-T Cells) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Criteria 

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
No Results Posted