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

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Overview

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. ACLX-001 is a BCMA directed CAR with a non-scFv binding domain that has been deimmunized.
SparkCures ID 1043
Trial Phase Phase 1
Enrollment 40 Patients
Treatments
Tags
Trial Sponsors
  • Kite, A Gilead Company
Trial Collaborators
  • Arcellx, Inc.
NCT Identifier

NCT04155749

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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Trial Links

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