The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Recruiting
Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| ALLO-647 | ALLO-647, ALLO-501 | |
| Fludarabine | ALLO-647, ALLO-501 | |
| Cyclophosphamide | ALLO-647, ALLO-501 |
| Name | Type | Description | Interventions |
|---|---|---|---|
| ALLO-647, ALLO-501 | Experimental |
|
Inclusion Criteria:
- Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular
Lymphoma.
- Relapse or refractory disease after at least 2 lines of chemotherapy
- At least 1 measurable lesion at time of screening.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Adequate hematological, renal, liver, pulmonary, and cardiac functions.
Exclusion Criteria:
- Current or history of central nervous system (CNS) lymphoma.
- Clinically significant CNS dysfunction.
- ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
- Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified
cell therapy or adoptive T cell therapy
- Systemic anticancer therapy within 2 weeks prior to study entry.
- On-going treatment with immunosuppressive agents.
- Active acute or chronic graft versus host disease (GvHD), or GvHD requiring
immunosuppressive treatment within 4 weeks of enrollment.
- Any form of primary or acquired immunodeficiency (e.g., severe combined
immunodeficiency disease).
- Current thyroid disorder (including hyperthyroidism), except for subjects with
hypothyroidism controlled on a stable dose of hormone replacement therapy.
- Patients unwilling to participate in an extended safety monitoring period
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501 |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion |
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Allogene Therapeutics |
May 13, 2021
