OncoMatch/Clinical Trials/NCT05437341
PSMA/CD70 Bi-specific CAR-T Cell Therapy
Is NCT05437341 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies bi-4SCAR PSMA/CD70 T cells for cancer disease.
Treatment: bi-4SCAR PSMA/CD70 T cells — The purpose of this study is to assess the feasibility, safety and efficacy of anti-PSMA/CD70 bi-specific CAR-T cell therapy in patients with CD70 and PSMA positive malignancies. Another goal of the study is to learn more about the function of the PSMA/CD70 bi-specific CAR-T cells and their persistency in patients.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CD70 overexpression (positive expression by antibody staining (IHC or flow cytometry))
The expression status of CD70 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by CD70 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses.
Required: FOLH1 overexpression (positive expression by antibody staining (IHC or flow cytometry))
The expression status of CD70 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by CD70 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses.
Prior therapy
Must have received: standard first-line therapy
Patients with tumor cells have received standard first-line therapy
Cannot have received: genetically engineered CD70 or PSMA-specific CAR T cells
Previous treatment with other genetically engineered CD70 or PSMA-specific CAR T cells
Lab requirements
Blood counts
WBC ≥1000/ul, ANC ≥500/ul, ALC ≥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
Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent. Pulse Ox greater than or equal to 90% on room air. Liver function: defined as alanine transaminase (ALT) <3x upper limit of normal (ULN), aspartate aminotransferase (AST) <3x ULN; serum bilirubin and alkaline phosphatase <2x ULN. Renal function: Patients must have 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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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