Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer
Trial Parameters
Brief Summary
This is single center, open-label phase I, non-randomized study which will enroll patients with recurrent advanced ovarian cancer to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T cells (fhB7H3.CAR-Ts) via using a '3+3+3' dose escalation design. In the dose expansion cohort, six patients will be enrolled to further assess their efficacy with the optimal dosage.
Eligibility Criteria
Inclusion Criteria: 1. Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production 2. Written informed consent and authorization for release of personal health information 3. Subject has adequate performance status as defined by ECOG score of ≤ 2. 4. Expected life expectancy is no less than 12 weeks. 5. Subjects must have histologically or cytologically confirmed ovarian cancer. And cancer tissue or ascitic cancer cells are measured positive for B7H3 expression. 6. Subjects must have recurrent or refractory disease after or during first-line treatment. Defined as: Radiographic progression or Continuous Elevation of CA125. 7. Subjects must have evaluable disease - defined as: Measurable disease with tumor length ≥ 10mm or enlarged lymph nodes ≥ 15mm according to RECIST v1.1 criteria. 8. Adequate organ function - defined as: 1. Blood routine: white blood cell count ≥ 3 × 10\^9 / L; neutro