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.
Recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| ALLO-647 | ALLO-605, ALLO-647 | |
| Fludarabine | ALLO-605, ALLO-647 | |
| Cyclophosphamide | ALLO-605, ALLO-647 |
| Name | Type | Description | Interventions |
|---|---|---|---|
| ALLO-605, ALLO-647 | Experimental |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| 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. |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion |
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Allogene Therapeutics |
August 11, 2021
