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NCT04416984 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma, sponsored by Allogene Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT04416984: Active Phase 1 study of Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma, sponsored by Allogene Therapeutics.
NCT04416984 is a Phase 1 study of Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma that is active but no longer recruiting, run by Allogene Therapeutics. The registered enrollment target is 160 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04416984, a Phase 1 study of Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by Allogene Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Primary Outcome
Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL ALLO-647
- GENETIC ALLO-501A
Study Locations (20)
California
- City of Hope - Duarte
- UCLA Medical Center - Los Angeles
- Stanford Cancer Institute - Palo Alto
Florida
- University of Miami - Miami
- Advent Health - Orlando
- Moffitt Cancer Center - Tampa
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic Hospital - Phoenix
Georgia
- Northside Hospital - Atlanta - Atlanta
- Augusta University - Augusta
Colorado
- Colorado Blood Cancer Institute - Denver
Connecticut
- Yale School of Medicine - New Haven
Illinois
- Loyola University Medical Center - Maywood
Kentucky
- Norton Cancer Institute - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2029-05 |
| Phase | Phase 1 |
What the registry record for NCT04416984 still lists
NCT04416984 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher).
The record links to 1 condition, with Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04416984 names 20 study sites across 14 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04416984 about?
NCT04416984 is a clinical study titled "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)". This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the...
What is the current status of trial NCT04416984?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2020-05-21. Estimated completion is 2029-05.
What conditions does trial NCT04416984 study?
This clinical trial studies the following conditions: Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT04416984?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), ALLO-647 (BIOLOGICAL), ALLO-501A (GENETIC).
Who is sponsoring clinical trial NCT04416984?
This trial is sponsored by Allogene Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04416984 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04416984's enrollment target sits among peer trials
160 340th of 2000 higher than 1,655 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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