OncoMatch/Clinical Trials/NCT05438368
GD2/CD70 Bi-specific CAR-T Cell Therapy
Is NCT05438368 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies bi-4SCAR GD2/CD70 T cells for cancer disease.
Treatment: bi-4SCAR GD2/CD70 T cells — The purpose of this study is to assess the feasibility, safety and efficacy of GD2/CD70 bi-specific CAR-T cell therapy in patients with GD2 and/or CD70 positive tumor. Another goal of the study is to learn more about the function of the GD2/CD70 bi-specific CAR-T cells and their persistency in patients.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: GD2 overexpression (positive expression by immunohistochemistry or flow cytometry)
The expression status of GD2 or CD70 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses.
Required: CD70 overexpression (positive expression by immunohistochemistry or flow cytometry)
The expression status of GD2 or CD70 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses.
Prior therapy
Must have received: standard first-line therapy
Patients with tumors received standard first-line therapy
Cannot have received: genetically engineered GD2 or CD70-specific CAR T cells
Previous treatment with other genetically engineered GD2 or CD70-specific CAR T cells.
Lab requirements
Blood counts
white blood cell count ≥1000/ul, absolute neutrophil count ≥500/ul, absolute lymphocyte count ≥500/ul, platelet count ≥25,000/ul (not achieved by transfusion)
Kidney function
serum creatinine less than 3 times upper limit of normal
Liver function
alt <3x uln, ast <3x uln; serum bilirubin and alkaline phosphatase <2x uln
Cardiac function
left ventricular ejection fraction greater than or equal to 40/55 percent
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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