OncoMatch/Clinical Trials/NCT05437328
GD2/CD56 Bi-specific CAR-T Cell Therapy
Is NCT05437328 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies bi-4SCAR GD2/CD56 T cells for malignant disease.
Treatment: bi-4SCAR GD2/CD56 T cells — The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/CD56 bi-specific CAR-T cell therapy in patients with GD2 and/or CD56 positive cancer. Another goal of the study is to learn more about the function of the anti-GD2/CD56 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 CD56 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and CD56 antibody staining results based on immunohistochemistry or flow cytometry analyses.
Required: NCAM1 overexpression (positive expression by immunohistochemistry or flow cytometry)
The expression status of GD2 or CD56 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and CD56 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 and have been judged to be non-resectable, metastatic, progressive or recurrent.
Cannot have received: genetically engineered GD2 or CD56-specific CAR T cells
Previous treatment with other genetically engineered GD2 or CD56-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 ≥40/55 percent
Liver function: ALT <3x ULN, AST <3x ULN; serum bilirubin and alkaline phosphatase <2x ULN. Renal function: serum creatinine less than 3 times upper limit of normal. Marrow function: 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). 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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