NCT05211557 Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 15 participants in total. It began in 2021-11-16 with a primary completion date of 2023-08-31.

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; 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 2. 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. 9. Not pregnant with negative serum pregnancy test within 3 days prior to enrollment. 10. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of highly effective methods of contraception from the time of informed consent until 8 weeks after study treatment discontinuation. \- Exclusion Criteria: 1. Subject has primary immunodeficiency syndrome or history of severe allergic reaction. 2. Subject has active infection with HIV, HTLV, HBV, HCV. 3. Subject has severe, uncontrolled intercurrent bacterial, viral or fungal infection. 4. Subject has a history of gastrointestinal perforation, clinical and/or radiographic evidence of bowel obstruction, or intra-abdominal abscess within 3 months prior to starting treatment. 5. Subject has active malignancy under treatment other than ovarian cancer. 6. Subject has Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention. 7. Subject is current using of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent. 8. Subject has not recovered from toxicity of previous anti-tumor treatment (CTCAE 5.0). 9. Subject is pregnant or breastfeeding. 10. Unwilling or unable to provide consent/assent for participation in the study. -

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