RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2023-03-13
Study Completion:2030-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05795595

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years.
  2. 2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
  3. 3. Eastern Cooperative Oncology Group performance status 0 or 1.
  4. 4. Adequate renal, liver, cardiac and pulmonary organ function.
  5. 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. 1. Prior treatment with anti-CD70 targeting agents
  2. 2. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
  3. 3. Presence of uncontrolled bacterial, viral, or fungal infection.
  4. 4. Active HIV, hepatitis B virus or hepatitis C virus infection.
  5. 5. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  6. 6. Women who are pregnant or breastfeeding.

Contacts and Locations

Study Contact

Central Trials
CONTACT
+1 (877) 214-4634
MedicalAffairs@crisprtx.com

Principal Investigator

Alissa Keegan, MD, PhD
STUDY_DIRECTOR
CRISPR Therapeutics

Study Locations (Sites)

Research Site 3
Duarte, California, 91010
United States
Research Site 7
Chicago, Illinois, 60637
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

Collaborators and Investigators

Sponsor: CRISPR Therapeutics AG

  • Alissa Keegan, MD, PhD, STUDY_DIRECTOR, CRISPR Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-13
Study Completion Date2030-05

Study Record Updates

Study Start Date2023-03-13
Study Completion Date2030-05

Terms related to this study

Keywords Provided by Researchers

  • CAR-T
  • Allogeneic
  • Carcinoma

Additional Relevant MeSH Terms

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