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ALLO-316

Phase 1

Advanced/Metastatic Clear Cell Renal Cell Carcinoma | Gene therapy | Oncology |Allogene Therapeutics, Inc.|Trials Updated: Aug 27, 2026

ALLO-316 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2021

ALLO-316 target and mechanism

Molecular targetCD70
ModalityGene therapy

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

FAST_TRACKRMAT

ALLO-316 clinical trials

ALLO-316 · 1 trial · 1 indication

Phase 1 1
NCT04696731Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell CarcinomaAdvanced/Metastatic Clear Cell Renal Cell Carcinoma
ACTIVE NOT_RECRUITING120 Analytics
PHASE1ACTIVE NOT_RECRUITING
Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Advanced/Metastatic Clear Cell Renal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
28 days
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
33 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALLO-647, ALLO-316EXPERIMENTAL -

Interventions

NameTypeDescription
ALLO-316GENETICALLO-316 is an allogeneic CAR T cell therapy targeting CD70
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 74 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Histologically confirmed renal cell carcinoma with a predominant clear cell component. * Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting. * At least one measurable lesion as defined by RECIST version 1.1 * Eastern Cooper...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 27, 2026NCT04696731lastUpdatePostDate: changed
LOWAug 27, 2026NCT04696731lastUpdatePostDate: changed

Frequently asked questions about ALLO-316

What is ALLO-316 used for in advanced or metastatic clear cell renal cell carcinoma?

ALLO-316 is an investigational gene therapy being studied for the treatment of advanced or metastatic clear cell renal cell carcinoma. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in a clinical trial to assess its safety and efficacy in this patient population.

What does ALLO-316 target?

ALLO-316 targets CD70, a protein expressed on certain cancer cells. By targeting CD70, the therapy is designed to recognize and attack CD70-positive tumor cells. This mechanism is being investigated in the context of advanced or metastatic clear cell renal cell carcinoma, where CD70 expression may play a role in disease progression.

Who makes ALLO-316?

ALLO-316 is being developed by Allogene Therapeutics, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol ALLO. The company is conducting clinical research on this investigational therapy for advanced or metastatic clear cell renal cell carcinoma.

What phase is ALLO-316 in?

ALLO-316 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. The therapy has been granted Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations by the FDA, which are intended to expedite the development and review of promising therapies.

What clinical trials is ALLO-316 in?

ALLO-316 is being studied in a Phase 1 clinical trial with the identifier NCT04696731. This trial is titled 'Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma' and is currently active but not recruiting. The study is enrolling approximately 120 participants in the United States.

Is ALLO-316 the same as any other drug?

ALLO-316 is the primary name for this investigational therapy. No alternative names have been reported for this drug. It is a gene therapy being developed by Allogene Therapeutics for the treatment of advanced or metastatic clear cell renal cell carcinoma.