OncoMatch/Clinical Trials/NCT06646627

Clinical Trial of Autologous B7-H3 CAR T Cells in Reoccurent Platinum-resistant Ovarian Tumors

Is NCT06646627 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies B7-H3CART for ovarian cancer.

Phase 1RecruitingStanford UniversityNCT06646627Data as of May 2026

Treatment: B7-H3CART — This is a single site, open label, Phase 1 study using a 3 + 3 dose escalation design in two cohorts of adults with recurrent, platinum-resistant ovarian tumors.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Biomarker criteria

Required: CD276 expression analysis required (B7-H3 positive expression NOT required for eligibility)

B7-H3 positive expression on malignant cells is NOT required but archival tissue must be available, or the subject must be willing to undergo tissue biopsy for expression analysis.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy

Lab requirements

Blood counts

Hgb ≥ 10 g/dL; ANC ≥ 1500/uL; Platelet count ≥ 100,000/uL; Absolute lymphocyte count ≥150/uL

Kidney function

Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min

Liver function

Serum ALT and AST ≤ 5x ULN (Grade 2); Total bilirubin ≤ 1.5x ULN (subjects with Gilbert's syndrome allowed if direct bilirubin within normal limits)

Cardiac function

Cardiac ejection fraction ≥ 45%; No evidence of physiologically significant pericardial effusion; No clinically significant ECG findings

Adequate bone marrow and major organ function. Hgb ≥ 10 g/dL; ANC ≥ 1500/uL; Platelet count ≥ 100,000/uL; Absolute lymphocyte count ≥150/uL; Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min; Serum ALT and AST ≤ 5x ULN (Grade 2); Total bilirubin ≤ 1.5x ULN (subjects with Gilbert's syndrome allowed if direct bilirubin within normal limits); PT or PTT ≤ 1.25 X ULN (not receiving therapeutic anticoagulation); Cardiac ejection fraction ≥ 45%; No evidence of physiologically significant pericardial effusion; No clinically significant ECG findings; Baseline oxygen saturation > 92% on room air

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Stanford University · Palo Alto, California

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