OncoMatch/Clinical Trials/NCT07067255
Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer
Is NCT07067255 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies GPC3 CD146 CAR-T cells for ovarian cancer.
Treatment: GPC3 CD146 CAR-T cells — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Ovarian Cancer
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT07067255 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy or other gene-engineered T-cell therapy targeting CD146 or GPC3 disqualifies patients from enrollment.
Does this trial require GPC3?
Yes, GPC3 positive expression is a required biomarker for enrollment.
Does this trial require MCAM?
Yes, MCAM positive expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 90 years or younger and at least 21 years old.
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