Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)
← catalyst calendarNCT04416984 · readout ≤ 924 d
Sponsored by Allogene Therapeutics (industry) · ALLO — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
160estimated
Sites
29
Countries
Australia, Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-05-21 | actual | When the study began enrolling |
| Primary completion | Feb 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2020-06-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
Interventions
- Genetic: ALLO-501A
- Biological: ALLO-647
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes
what the primary-completion date above is the date OFPhase 1a: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A
measured 28 days
Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A
measured 33 days
Phase 1b: Frequency and severity of ALLO-501A treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
measured Up to 60 months
Phase 2: Overall Response Rate (ORR) assessed per Independent Review Committee (IRC)
measured Up to 60 months
Publications
- PMID 39946666 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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