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ALLO-501A

Phase 1

Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma | Gene therapy | Oncology |Allogene Therapeutics, Inc.|Last Updated: Mar 4, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment160

FDA Designations

RMAT

Clinical trial landscape

ALLO-501A · 1 trial · 1 indication

Phase 1 1
NCT04416984Safety 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)Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
ACTIVE NOT_RECRUITING160 Analytics
PHASE1ACTIVE NOT_RECRUITING
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)
Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A
28 days

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

Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A
33 days

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

Phase 1b: Frequency and severity of ALLO-501A treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
Up to 60 months
Phase 2: Overall Response Rate (ORR) assessed per Independent Review Committee (IRC)
Up to 60 months

ORR defined as assessment of CR and PR using Lugano classification criteria 2014

Secondary Endpoints

Phase 1a, 1b, and 2: Duration of Response (DOR) assessed per IRC (Phase 2 only) and per investigator
Up to 60 months
Phase 1a, 1b, and 2: Overall Response Rate (ORR) assessed per investigator
Up to 60 months
Phase 1a, 1b, and 2: Best overall response (CR, PR, SD, PD) assessed per IRC (Phase 2 only) and per investigator
Up to 60 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALLO-501A, ALLO-647EXPERIMENTAL -

Interventions

NameTypeDescription
ALLO-501AGENETICALLO-501A 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 Sites29

Inclusion Criteria: For subjects with LBCL: * Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017 * At least 1 measurable lesion at time of enrollment * Relapsed or refractory disease after at least 2 lines of chemotherapy * Absence of signi...

Countries:United StatesAustraliaCanada
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Frequently asked questions about ALLO-501A

What is ALLO-501A used for?

ALLO-501A is an investigational allogeneic CAR T cell therapy being studied for the treatment of relapsed or refractory large B cell lymphoma, relapsed or refractory chronic lymphocytic leukemia, and relapsed or refractory small lymphocytic lymphoma. It is currently in Phase 1 clinical development.

What does ALLO-501A target?

ALLO-501A targets CD19, a protein found on the surface of B cells. It is an allogeneic CAR T cell therapy, meaning the T cells are derived from a healthy donor rather than from the patient. This approach is being studied in patients with certain relapsed or refractory B cell malignancies.

Who is developing ALLO-501A?

ALLO-501A is being developed by Allogene Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ALLO. Allogene is focused on developing allogeneic CAR T cell therapies for cancer.

What phase is ALLO-501A in?

ALLO-501A is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The drug has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, which is intended to expedite development of regenerative medicine therapies.

What clinical trials is ALLO-501A in?

ALLO-501A is being studied in a Phase 1 clinical trial with the identifier NCT04416984. This trial, known as ALPHA2, is evaluating the safety and efficacy of ALLO-501A in adults with relapsed or refractory large B cell lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma. The trial is active but not recruiting participants.

Is ALLO-501A the same as ALLO-501?

ALLO-501A is a distinct investigational product from ALLO-501. While both are allogeneic CAR T cell therapies targeting CD19, ALLO-501A is being studied in the ALPHA2 trial (NCT04416984) for relapsed or refractory large B cell lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma. The two products are not interchangeable.