Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma

Gilead Sciences

Status and phase: Active, not recruiting; Phase 1

Conditions: Relapsed and Refractory Multiple Myeloma

Treatments: Drug: anitocabtagene-autoleucel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04155749

ARC-101-ARM1

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

ARM 1

Experimental group

Description:

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

Treatment:

Drug: anitocabtagene-autoleucel