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OncoMatch/Clinical Trials/NCT07067255

Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer

Is NCT07067255 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies GPC3 CD146 CAR-T cells for ovarian cancer.

Phase 1/2RecruitingEssen BiotechNCT07067255Data as of May 2026

Treatment: GPC3 CD146 CAR-T cellsThis is a multicenter, open-label Phase 1/2 clinical trial evaluating the safety and preliminary efficacy of sequentially administered CD146-targeted and GPC3-targeted CAR-T cell therapy in patients with advanced relapsed or refractory ovarian cancer. Eligible patients will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of autologous CD146-directed CAR-T cells (Arm A) and a subsequent infusion of autologous GPC3-directed CAR-T cells (Arm B). The Phase 1 portion will assess safety, tolerability, and dose-limiting toxicities (DLTs) to determine a recommended Phase 2 dose, while the Phase 2 portion will evaluate efficacy endpoints including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Patients will be followed for up to 36 months after CAR-T infusion to monitor long-term outcomes and adverse events.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Sarcoma

Biomarker criteria

Required: GPC3 positive expression (positive)

Required: MCAM positive expression (positive)

Disease stage

Required: Stage IV

Metastatic disease required

Ovarian Cancer Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy

Patients must have received and progressed on or after at least one line of platinum-based chemotherapy (or be platinum-resistant)

Cannot have received: CAR-T cell therapy or other gene-engineered T-cell therapy targeting CD146 or GPC3

Previous treatment with any CAR-T cell therapy or other gene-engineered T-cell therapy targeting CD146 or GPC3

Lab requirements

Blood counts

absolute neutrophil count (anc) above a minimum threshold, platelet count above threshold, hemoglobin above threshold (transfusion allowed)

Kidney function

creatinine clearance ≥50 ml/min or per protocol criteria

Liver function

serum ast/alt and bilirubin ≤2× upper limit of normal (unless due to liver involvement by tumor)

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

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