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ALLO-501

Phase 1

Relapsed/Refractory Large B Cell Lymphoma | Gene therapy | Oncology |Allogene Therapeutics, Inc.|Last Updated: Mar 2, 2026

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment50
FDA Designations
RMAT
Clinical trial landscape

ALLO-501 · 1 trial · 2 indications

Phase 1 1
NCT03939026Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular LymphomaRelapsed/Refractory Large B Cell Lymphoma
COMPLETED50 Analytics
PHASE1COMPLETED
Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
Relapsed/Refractory Large B Cell Lymphoma
NCT0393902650
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Study Endpoints
Primary Endpoints
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
28 days

Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion

Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
33 days

Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALLO-647, ALLO-501EXPERIMENTAL -
Interventions
NameTypeDescription
ALLO-501GENETICALLO-501 is an allogeneic CAR T cell therapy targeting CD19
ALLO-647BIOLOGICALALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
FludarabineDRUGChemotherapy for lymphodepletion
CyclophosphamideDRUGChemotherapy for lymphodepletion
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

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 ...

Countries:United States
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