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

Description

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.

Conditions

Clear Cell Renal Cell Carcinoma, Cervical Carcinoma, Esophageal Carcinoma, Pancreatic Adenocarcinoma, Malignant Pleural Mesothelioma

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Study Overview

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Study Details

Study 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.

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

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

Condition
Clear Cell Renal Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Duarte

Research Site 3, Duarte, California, United States, 91010

Chicago

Research Site 7, Chicago, Illinois, United States, 60637

Boston

Research Site 6, Boston, Massachusetts, United States, 02215

Saint Louis

Research Site 2, Saint Louis, Missouri, United States, 63110

Durham

Research Site 4, Durham, North Carolina, United States, 27710

Nashville

Research Site 1, Nashville, Tennessee, United States, 37203

Houston

Research Site 5, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CRISPR Therapeutics AG,

Alissa Keegan, MD, PhD, STUDY_DIRECTOR, CRISPR Therapeutics

Study Record Dates

2030-05