Overview

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