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ALLO-316

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

FAST_TRACKRMAT

Clinical trial landscape

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
MEDIUMJul 17, 2026NCT04696731primaryCompletionDate: changed
MEDIUMJul 17, 2026NCT04696731primaryCompletionDate: 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.

Who makes ALLO-316?

ALLO-316 is being developed by Allogene Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALLO. The company is conducting clinical research on this investigational gene 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 been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting participants, and the drug has received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA.

What clinical trials is ALLO-316 in?

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

Is ALLO-316 FDA approved?

ALLO-316 is not FDA approved. It is an investigational gene therapy currently in Phase 1 clinical development for advanced or metastatic clear cell renal cell carcinoma. The FDA has granted it Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations, which are intended to expedite development and review of promising therapies.