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

Sponsor

Allogene Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05000450

Collaborator

(none)

136

Enrollment

Locations

Arm

66.9

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory Multiple Myeloma	Genetic: ALLO-605 Biological: ALLO-647 Drug: Fludarabine Drug: Cyclophosphamide	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Actual Study Start Date :

Jun 6, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALLO-605, ALLO-647	Genetic: ALLO-605 ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product Biological: ALLO-647 ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen Drug: Fludarabine Chemotherapy for lymphodepletion Drug: Cyclophosphamide Chemotherapy for lymphodepletion

Arm

Intervention/Treatment

Experimental: ALLO-605, ALLO-647

Genetic: ALLO-605

ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product

Biological: ALLO-647

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Drug: Fludarabine

Chemotherapy for lymphodepletion

Drug: Cyclophosphamide

Chemotherapy for lymphodepletion

Outcome Measures

Primary Outcome Measures

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 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 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR) [12 months of study follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sarah Cannon/Colorado Blood Cancer Institute	Denver	Colorado	United States	80218
2	St. David's South Austin Medical Center	Austin	Texas	United States	78704
3	MD Anderson Cancer Center	Houston	Texas	United States	77030
4	Texas Transplant Institute	San Antonio	Texas	United States	78229