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

Relapsed/Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05000450
• Other study ID #: ALLO-605-201
• Secondary ID: IGNITE Study
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: June 6, 2021
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: Allogene Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

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
• Cyclophosphamide
Chemotherapy for lymphodepletion

Locations

Country	Name	City	State
United States	St. David's South Austin Medical Center	Austin	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Texas Transplant Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Allogene Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion	28 days
Primary	Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605]	Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 30 days following 1st infusion	30 days
Primary	Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR)		12 months of study follow-up