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CTX131

Phase 1

Clear Cell Renal Cell Carcinoma | Monoclonal antibody | Oncology |CRISPR Therapeutics AG|Last Updated: Nov 26, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05795595A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid TumorsPHASE1 COMPLETED 19Mar 13, 2023Sep 18, 2025Nov 26, 20257 United States
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Study Endpoints
Primary Endpoints
Phase 1 (Dose Escalation): Incidence of adverse events
From CTX131 infusion up to 28 days post-infusion

Defined as dose-limiting toxicities

Phase 2 (Cohort Expansion): Objective response rate (ORR)
From CTX131 infusion up to 60 months post-infusion

ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CTX131EXPERIMENTALAdministered by IV infusion following lymphodepleting chemotherapy.
Interventions
NameTypeDescription
CTX131BIOLOGICALCTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: 1. Age ≥18 years. 2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma. 3. Eastern Cooperative Oncology Group performance status 0 or 1. 4....

Countries:United States
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