A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors

Sponsor: CRISPR Therapeutics AG

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05795595

Patient View

This Phase 1/2 open-label, multicenter study assesses CTX131, a CD70-directed CAR T-cell therapy using CRISPR-Cas9 gene editing, in adults with relapsed/refractory solid tumors. Eligible participants are ≥18 years with specific cancers, good organ function, and ECOG status 0-1. Both genders must use contraception post-infusion.

Patient Parameters

Program Overview

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.

Description

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).

Eligibility Criteria

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. Adequate renal, liver, cardiac and pulmonary organ function.
  5. 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

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

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