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

• Status: Recruiting
• Trial end date: 2035-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcellx, Inc.

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