Esophageal Cancer Clinical Trial

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

Summary

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131â„¢ in subjects with relapsed or refractory solid tumors.

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Full 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).

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Eligibility Criteria

Key Inclusion Criteria:

Age ≥18 years.
Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, endometrial 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.

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

250

Study ID:

NCT05795595

Recruitment Status:

Recruiting

Sponsor:

CRISPR Therapeutics AG

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There are 6 Locations for this study

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Research Site 3
Duarte California, 91010, United States
Research Site 6
Boston Massachusetts, 02215, United States
Research Site 2
Saint Louis Missouri, 63110, United States
Research Site 4
Durham North Carolina, 27710, United States
Research Site 1
Nashville Tennessee, 37203, United States
Research Site 5
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

250

Study ID:

NCT05795595

Recruitment Status:

Recruiting

Sponsor:


CRISPR Therapeutics AG

How clear is this clinincal trial information?

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