CompletedPhase 1/2

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

United States19 participantsStarted 2023-03-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

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.

What they're measuring

Phase 1 (Dose Escalation): Incidence of adverse events

Timeframe: From CTX131 infusion up to 28 days post-infusion

Phase 2 (Cohort Expansion): Objective response rate (ORR)

Timeframe: From CTX131 infusion up to 60 months post-infusion

Trial details

NCT IDNCT05795595

SponsorCRISPR Therapeutics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-18

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