A Safety and Efficacy Study Evaluating… | Clinical Trial

Key information

Conditions

Clear Cell Renal Cell Carcinoma Adenocarcinoma Adenoma Carcinoma Carcinoma, Renal Cell Cervical Carcinoma Digestive System Diseases Digestive System Neoplasms Esophageal Carcinoma Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Malignant Pleural Mesothelioma Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pancreatic Adenocarcinoma Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site 3, Duarte, California, United States

About this study

An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Age ≥18 years.
Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
Eastern Cooperative Oncology Group performance status 0 or 1.
Adequate renal, liver, cardiac and pulmonary organ function.
Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX131 infusion.

Key Exclusion Criteria:

Prior treatment with anti-CD70 targeting agents
History of certain central nervous system (CNS), cardiac or pulmonary conditions.
Presence of uncontrolled bacterial, viral, or fungal infection.
Active HIV, hepatitis B virus or hepatitis C virus infection.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
Women who are pregnant or breastfeeding.

Treatment and study plan

CTX131

Biological

CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Primary outcomes

Phase 1 (Dose Escalation): Incidence of adverse events

Time frame: From CTX131 infusion up to 28 days post-infusion

Defined as dose-limiting toxicities
Phase 2 (Cohort Expansion): Objective response rate (ORR)

Time frame: 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

Sponsors and collaborators

Lead sponsor

CRISPR Therapeutics AG

Industry

Registry information

Official study title

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or Refractory Solid Tumors

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Apr 3, 2023
Registry last updated: Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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