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ALLO-316

Phase 1

Advanced/Metastatic Clear Cell Renal Cell Carcinoma | Gene therapy | Oncology |Allogene Therapeutics, Inc.|Last Updated: Sep 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
FAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04696731Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell CarcinomaPHASE1 ACTIVE NOT_RECRUITING 120Feb 24, 2021Dec 1, 2025Sep 25, 202510 United States
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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 — 75 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)
LOWMay 26, 2026NCT04696731primaryCompletionDate: changed
LOWMay 24, 2026NCT04696731studyFirstPostDate: changed