Clinical trial · Interventional
Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
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 Follicular Lymphoma | — | UNRESOLVED | — |
| Relapsed/Refractory Large B Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALLO-501 | 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-647, ALLO-501
- interventionNames
- Genetic: ALLO-501
- Biological: ALLO-647
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (2)
- measure
- Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
- timeFrame
- 28 days
- description
- Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
- measure
- Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
- timeFrame
- 33 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLocke FL, Munoz JL, Tees MT, Lekakis LJ, de Vos S, Nath R, Stevens DA, Malik SA, Shouse GP, Hamadani M, Oluwole OO, Perales MA, Miklos DB, Fisher PW, Feng A, Navale L, Le Gall JB, Neelapu SS. Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies. J Clin Oncol. 2025 May 10;43(14):1695-1705. doi: 10.1200/JCO-24-01933. Epub 2025 Feb 13. PMID 39946666