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CTX131

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

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

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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 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
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Frequently asked questions about CTX131

What is CTX131 used for?

CTX131 is an investigational therapy being studied for the treatment of relapsed or refractory solid tumors and hematologic malignancies. In clinical trials, it is evaluated in conditions including T Cell Lymphoma, Clear Cell Renal Cell Carcinoma, cervical carcinoma, esophageal carcinoma, pancreatic adenocarcinoma, malignant pleural mesothelioma, B Cell Lymphoma, and Acute Myeloid Leukemia.

Who makes CTX131?

CTX131 is being developed by CRISPR Therapeutics AG, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRSP.

What phase is CTX131 in?

CTX131 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one in solid tumors and one in hematologic malignancies.

What clinical trials is CTX131 in?

CTX131 has been evaluated in two completed Phase 1 trials. NCT05795595 studied CTX131 in adults with relapsed or refractory solid tumors, enrolling 19 participants in the United States. NCT06492304 studied CTX131 in adults with relapsed or refractory hematologic malignancies, enrolling 12 participants in the United States and Australia.

Is CTX131 the same as a monoclonal antibody?

CTX131 is classified as a monoclonal antibody modality in its development program. However, the specific molecular target of CTX131 has not been disclosed in the available clinical trial information.