OncoMatch/Clinical Trials/NCT05211557
Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer
Is NCT05211557 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Ovarian Cancer
Biomarker criteria
Required: CD276 positive expression (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT05211557 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CD276?
Yes, CD276 positive expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages