Clinical trial · Interventional
Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated (Halted Prematurely)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALLO-605 | Genetic | — | UNRESOLVED |
| ALLO-647 | Biological | Alemtuzumab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALLO-605, ALLO-647
- interventionNames
- Genetic: ALLO-605
- Biological: ALLO-647
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (3)
- 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
- description
- Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available