Back to resultsSafety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Primary Purpose
Relapsed/Refractory Multiple Myeloma
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALLO-605
ALLO-647
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-605, ALLO-647, Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
- St. David's South Austin Medical Center
- MD Anderson Cancer Center
- Texas Transplant Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALLO-605, ALLO-647
Arm Description
Outcomes
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.
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]
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05000450
Brief Title
Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allogene Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
Keywords
CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-605, ALLO-647, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALLO-605, ALLO-647
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
ALLO-605
Intervention Description
ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product
Intervention Type
Biological
Intervention Name(s)
ALLO-647
Intervention Description
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Chemotherapy for lymphodepletion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Chemotherapy for lymphodepletion
Primary Outcome Measure Information:
Title
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.
Description
Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion
Time Frame
28 days
Title
Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605]
Description
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 30 days following 1st infusion
Time Frame
30 days
Title
Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR)
Time Frame
12 months of study follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. David's South Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
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