OncoMatch/Clinical Trials/NCT05211557
Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer
Is NCT05211557 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies fhB7H3.CAR-Ts for ovarian cancer.
Treatment: fhB7H3.CAR-Ts — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Required: CD276 positive expression (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
white blood cell count ≥ 3 × 10^9 / L; neutrophil count ≥ 1.5 × 10^9 / L; hemoglobin ≥ 9g/dL; platelet count ≥ 80 × 10^9 / L
Kidney function
Urea and serum creatinine ≤ 1.5 × ULN
Liver function
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; INR < 1.5 × ULN; PT, APTT < 1.5 × ULN
Cardiac function
Left ventricular ejection fraction ≥ 40%; Baseline oxygen saturation ≥ 95%
Adequate organ function - defined as: Blood routine: white blood cell count ≥ 3 × 10^9 / L; neutrophil count ≥ 1.5 × 10^9 / L; hemoglobin ≥ 9g/dL; platelet count ≥ 80 × 10^9 / L; INR< 1.5 × ULN; PT, APTT< 1.5 × ULN. The liver, kidney, lung and cardiopulmonary function: Urea and serum creatinine ≤ 1.5 × ULN; Left ventricular ejection fraction ≥ 40%; Baseline oxygen saturation ≥ 95%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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