Clinical Trials /

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

NCT04155749

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: ARC-101
  • NCT ID: NCT04155749

Conditions

  • Relapsed and Refractory Multiple Myeloma

Interventions

DrugSynonymsArms
CART-ddBCMAARM 1

Purpose

Master protocol for cell therapy, Phase 1 proof-of-concept studies., in relapsed and refractory multiple myeloma and includes long-term safety follow-up.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
ARM 1ExperimentalPhase 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
  • CART-ddBCMA

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)
Time Frame:24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Best overall response (BOR) and ORR by IMWG Consensus Criteria
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arcellx, Inc.

Trial Keywords

  • BCMA
  • Myeloma
  • Chimeric

Last Updated

November 12, 2019