Recent Updates
Recently added Catalysts

CTX131

Phase 1

Clear Cell Renal Cell Carcinoma | Monoclonal antibody | Oncology |CRISPR Therapeutics AG|Trials Updated: Apr 3, 2026

CTX131 development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since Apr 2023

CTX131 target and mechanism

Molecular targetCD70
ModalityMonoclonal antibody

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment31

FDA Designations

No designations recorded

CTX131 clinical trials

CTX131 · 2 trials · 8 indications

Phase 1 2
NCT06492304A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed/Refractory Hematologic MalignanciesT Cell Lymphoma
COMPLETED12 Analytics
NCT05795595A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid TumorsClear Cell Renal Cell Carcinoma
COMPLETED19 Analytics
PHASE1COMPLETED
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed/Refractory Hematologic Malignancies
T Cell LymphomaUnlock trial analytics
PHASE1COMPLETED
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
Clear Cell Renal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1 Part A (dose escalation) and Part B (dose optimization in selected disease types):
From CTX131 infusion up to 28 days post-infusion

For all cohorts: Incidence of Adverse events defined as dose-limiting toxicities

Objective Response rate (ORR)
From CTX131 infusion up to 60 months post-infusion

Phase 2 (expansion of selected Phase 1 disease types)

Composite Complete Remission (CRc)
From CTX131 infusion up to 60 months post-infusion

Phase 2 (expansion of selected Phase 1 disease types)

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

Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. ≥18 years of age 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (ECOG status of 2 will be permitted for subjects with AML) 3. Diagnosed with r/r T Cell Lymphoma (TCL), B Cell Lymphoma (BCL), or Acute Myeloid Leukemia (AML) T cell lymphoma, including St...

Countries:United StatesAustralia
Unlock Eligibility Criteria

Frequently asked questions about CTX131

What is CTX131?

CTX131 is an investigational monoclonal antibody developed by CRISPR Therapeutics AG that targets CD70. It is being studied in Phase 1 clinical trials for the treatment of clear cell renal cell carcinoma and T cell lymphoma, as well as other hematologic and solid tumor malignancies.

What is CTX131 used for?

CTX131 is being evaluated for the treatment of clear cell renal cell carcinoma and T cell lymphoma. Clinical trials have also included patients with B cell lymphoma, acute myeloid leukemia, cervical carcinoma, esophageal carcinoma, pancreatic adenocarcinoma, and malignant pleural mesothelioma.

What does CTX131 target?

CTX131 targets CD70, a protein expressed on certain hematologic and solid tumor cells. By binding to CD70, CTX131 is designed to direct an immune response against CD70-positive cancer cells. This mechanism is under investigation in Phase 1 trials.

Who is developing CTX131?

CTX131 is being developed by CRISPR Therapeutics AG, a biopharmaceutical company traded on the Nasdaq under the ticker symbol CRSP. The company is responsible for the clinical development of CTX131.

What phase is CTX131 in?

CTX131 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any regulatory agency. The Phase 1 trials have been completed, and further studies may be planned.

What clinical trials is CTX131 in?

CTX131 has been studied in two completed Phase 1 trials: NCT05795595 in relapsed or refractory solid tumors, including clear cell renal cell carcinoma, and NCT06492304 in relapsed or refractory hematologic malignancies, including T cell lymphoma. Both trials enrolled adult participants.