The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Recruiting
Phase 1/Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| ALLO-647 | ALLO-501A, ALLO-647 | |
| Fludarabine | ALLO-501A, ALLO-647 | |
| Cyclophosphamide | ALLO-501A, ALLO-647 |
| Name | Type | Description | Interventions |
|---|---|---|---|
| ALLO-501A, ALLO-647 | Experimental |
|
Inclusion Criteria:
- Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at
last relapse.
- At least 1 measurable lesion at time of enrollment.
- Relapsed or refractory disease after at least 2 lines of chemotherapy
- ECOG performance status 0 or 1.
- Absence of donor (product)-specific anti-HLA antibodies (DSA).
- Adequate hematological, renal and liver function.
Exclusion Criteria:
- Current or history of central nervous system (CNS) lymphoma.
- Clinically significant CNS dysfunction
- Any other active malignancy within 3 years prior to enrollment, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Radiation therapy within 2 weeks prior to ALLO-647.
- Prior irradiation to >25% of the bone marrow.
- Donor lymphocyte infusion (DLI) within 30 days prior to ALLO-647.
- Patients unwilling to participate in an extended safety monitoring period
| Maximum Eligible Age: | 79 Years |
| 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-501A |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | Dose limiting toxicity is defined as protocol-defined ALLO-501A-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 |
May 13, 2021
