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

Last updated: June 24, 2024
Sponsor: CRISPR Therapeutics AG
Overall Status: Active - Recruiting

Phase

1/2

Condition

Carcinoma

Cancer/tumors

Pancreatic Cancer

Treatment

CTX131

Clinical Study ID

NCT05795595
CRSP-ONC-005
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 malignantpleural 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 useacceptable method(s) of contraception from enrollment through at least 12 monthsafter CTX131 infusion.

Exclusion

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 steroidsand/or other immunosuppressive therapy.

  6. Women who are pregnant or breastfeeding.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: CTX131
Phase: 1/2
Study Start date:
March 13, 2023
Estimated Completion Date:
May 31, 2030

Study 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).

Connect with a study center

  • Research Site 3

    Duarte, California 91010
    United States

    Active - Recruiting

  • Research Site 7

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site 6

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Research Site 2

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Research Site 4

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Research Site 1

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research Site 5

    Houston, Texas 77030
    United States

    Active - Recruiting

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