Relapsed/Refractory Multiple Myeloma
Conditions
Keywords
CAR T, Cell Therapy, Allogeneic Cell Therapy, Cellular Immuno-therapy, AlloCAR T, ALLO-605, ALLO-647, Multiple Myeloma
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.
Interventions
GENETICALLO-605
ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product
BIOLOGICALALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
DRUGFludarabine
Chemotherapy for lymphodepletion
DRUGCyclophosphamide
Chemotherapy for lymphodepletion
Sponsors
Allogene Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed