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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 LymphomaUnlock trial analytics

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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Frequently asked questions about ALLO-501

What is ALLO-501 used for?

ALLO-501 is an investigational allogeneic CAR T cell therapy being studied for the treatment of relapsed/refractory large B cell lymphoma and relapsed/refractory follicular lymphoma. It is a gene therapy developed by Allogene Therapeutics, Inc. (NASDAQ: ALLO) and is currently in Phase 1 clinical development.

What does ALLO-501 target?

ALLO-501 targets CD19, a protein expressed on B cells. It is an anti-CD19 allogeneic CAR T cell therapy, meaning it uses donor-derived T cells engineered to recognize and attack CD19-positive cancer cells. This mechanism is being evaluated in patients with relapsed/refractory large B cell lymphoma and follicular lymphoma.

Who makes ALLO-501?

ALLO-501 is being developed by Allogene Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ALLO. The company is focused on developing allogeneic CAR T cell therapies for cancer treatment.

What phase is ALLO-501 in?

ALLO-501 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 the development and review of regenerative medicine therapies.

What clinical trials is ALLO-501 in?

ALLO-501 has been studied in one completed Phase 1 clinical trial, NCT03939026, which evaluated the safety and efficacy of ALLO-501 in adults with relapsed/refractory large B cell lymphoma or follicular lymphoma. The trial enrolled 50 participants in the United States and was not randomized or blinded.

Is ALLO-501 the same as an anti-CD19 CAR T therapy?

Yes, ALLO-501 is an anti-CD19 allogeneic CAR T cell therapy. It is designed to target CD19, a protein found on B cells, and is being investigated for the treatment of certain B cell lymphomas. The therapy is distinct from autologous CAR T therapies because it uses donor-derived cells.