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

Published: April 14, 2023

Primary Outcome Measures

  1. Phase 1 (Dose Escalation): Incidence of adverse events [ Time Frame: From CTX131 infusion up to 28 days post-infusion ]
    Defined as dose-limiting toxicities
  2. Phase 2 (Cohort Expansion): Objective response rate (ORR) [ Time Frame: From CTX131 infusion up to 60 months post-infusion ]
    ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology

Inclusion Criteria

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

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.
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