Clinical trial NCT05000450: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Relapsed/Refractory Multiple Myeloma
Keywords: CAR T
Cell Therapy
Allogeneic Cell Therapy
Cellular Immuno-therapy
AlloCAR T
ALLO-605
ALLO-647
Multiple Myeloma
Lead sponsor: Allogene Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-08-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: 28 days
measure: Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605]
timeFrame: 30 days
measure: Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR)
timeFrame: 12 months of study follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon/Colorado Blood Cancer Institute
state: Colorado
city: Austin
country: United States
facility: St. David's South Austin Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Texas Transplant Institute
state: Texas
Study officials:
References: