Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Phase 1

Terminated

• Conditions: Relapsed/Refractory Multiple Myeloma
• Interventions: Genetic: ALLO-605; Biological: ALLO-647; Drug: Fludarabine; Drug: Cyclophosphamide

• Registration Number: NCT05000450
• Lead Sponsor: Allogene Therapeutics

Brief Summary

The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-06
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Study First Posted: 2021-08-11
• Primary Completion: 2023-10-11
• Study Completion: 2023-10-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Documented diagnosis of relapsed/refractory multiple myeloma (MM)
• Subjects must have measurable disease
• Subjects must have received ≥3 prior MM lines of therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic, renal, liver, pulmonary, and cardiac functions
• Life expectancy of at least 3 months without treatment

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Exclusion Criteria

• Subjects with known active or history of central nervous system (CNS) or leptomeningeal involvement of myeloma or plasma cell leukemia
• Current or history of thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
• Autologous stem cell transplantation within last 6 weeks prior to the start of lymphodepletion
• Any prior allogeneic hematopoietic stem cell transplantation
• Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALLO-605, ALLO-647	Fludarabine	-
ALLO-605, ALLO-647	ALLO-605	-
ALLO-605, ALLO-647	ALLO-647	-
ALLO-605, ALLO-647	Cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605]	30 days	Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 30 days following 1st infusion
Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-605 that will determine MTD/MAD and select the recommended Phase 2 dose (RP2D) of ALLO-605.	28 days	Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion
Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR)	12 months of study follow-up

Trial Locations

Locations (4)

St. David's South Austin Medical Center; 🇺🇸 Austin, Texas, United States

Sarah Cannon/Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Texas Transplant Institute; 🇺🇸 San Antonio, Texas, United States