OncoMatch/Clinical Trials/NCT07066982
Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas
Is NCT07066982 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CD146/HER2 CAR-T cells for sarcoma.
Treatment: CD146/HER2 CAR-T cells — This is an open-label, non-randomized, multicenter Phase 1/2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells. The Phase 1 portion will employ a dose-escalation design to assess safety and determine the recommended Phase 2 dose, while the Phase 2 expansion will evaluate preliminary efficacy (tumor response and survival outcomes). Approximately 40 patients (children and adults) with relapsed or refractory sarcomas will be enrolled across multiple centers. All participants will be followed for up to 36 months to monitor dose-limiting toxicities, objective response rates, progression-free survival, overall survival, and long-term safety.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Biomarker criteria
Allowed: MCAM overexpression
Expression of CD146 and/or HER2 in the tumor is recommended (as assessed by immunohistochemistry or flow cytometry on a tumor sample). Note: At least one of the target antigens (CD146 or HER2) should be present on the tumor; if feasible, patients should have tumor tissue tested for these markers. (In cases where testing is unavailable, enrollment may proceed based on histology known to often express these targets, per investigator judgment.)
Allowed: HER2 (ERBB2) overexpression
Expression of CD146 and/or HER2 in the tumor is recommended (as assessed by immunohistochemistry or flow cytometry on a tumor sample). Note: At least one of the target antigens (CD146 or HER2) should be present on the tumor; if feasible, patients should have tumor tissue tested for these markers. (In cases where testing is unavailable, enrollment may proceed based on histology known to often express these targets, per investigator judgment.)
Disease stage
Grade: high-grade
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — sarcoma
Patients should have received and progressed on or not be candidates for standard first-line treatments. There is no limit on number of prior lines of therapy, but at least one prior systemic therapy for sarcoma is typically required (unless no standard therapy exists for the subtype).
Cannot have received: CAR-T cell therapy
Prior treatment with any CAR-T cell therapy or other gene-modified T-cell therapy is excluded.
Cannot have received: gene-modified T-cell therapy
Prior treatment with any CAR-T cell therapy or other gene-modified T-cell therapy is excluded.
Lab requirements
Blood counts
absolute neutrophil count ≥1.0×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥8 g/dL
Kidney function
creatinine clearance ≥50 mL/min or age-appropriate normal
Liver function
bilirubin ≤1.5× ULN, AST/ALT ≤2.5× ULN
Cardiac function
ejection fraction ≥50%; baseline oxygen saturation >92% on room air
Adequate organ function to undergo cytotoxic chemotherapy and cell transfer therapy, including: cardiac ejection fraction ≥50%; baseline oxygen saturation >92% on room air; adequate bone marrow reserves (absolute neutrophil count ≥1.0×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥8 g/dL), hepatic function (e.g. bilirubin ≤1.5× ULN, AST/ALT ≤2.5× ULN), and renal function (e.g. creatinine clearance ≥50 mL/min or age-appropriate normal).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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