Evaluating CTX131 for treating advanced 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

This study is testing a new treatment called CTX131, which uses modified immune cells to see if it can help adults with hard-to-treat solid tumors feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CRISPR Therapeutics (industry)
• Drugs / interventions: chimeric antigen receptor, immunotherapy
• Locations: 7 sites (Duarte, California and 6 other locations)
• Trial ID: NCT05795595 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1/2 study assesses the safety and efficacy of CTX131, an allogeneic CAR T cell immunotherapy, in adult patients with relapsed or refractory solid tumors. The therapy utilizes genetically modified T cells targeting CD70, created using CRISPR-Cas9 technology. Participants will receive CTX131 and be monitored for treatment outcomes and safety over the course of the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, or malignant pleural mesothelioma.

Not a fit: Patients with prior treatment using anti-CD70 agents or those with certain uncontrolled infections or autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.

How similar studies have performed: While CAR T cell therapies have shown promise in hematological malignancies, this approach in solid tumors is still being explored and is considered novel.

Eligibility criteria

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 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.

Where this trial is running

Duarte, California and 6 other locations

• Research Site 3 — Duarte, California, United States (RECRUITING)
• Research Site 7 — Chicago, Illinois, United States (RECRUITING)
• Research Site 6 — Boston, Massachusetts, United States (RECRUITING)
• Research Site 2 — Saint Louis, Missouri, United States (RECRUITING)
• Research Site 4 — Durham, North Carolina, United States (RECRUITING)
• Research Site 1 — Nashville, Tennessee, United States (RECRUITING)
• Research Site 5 — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Central Trials

Conditions: Clear Cell Renal Cell Carcinoma, Cervical Carcinoma, Esophageal Carcinoma, Pancreatic Adenocarcinoma, Malignant Pleural Mesothelioma, CAR-T, Allogeneic, Carcinoma