PSMA-specific CAR-T Cell Therapy

A vizsgálat adatai

Ki végzi

Shenzhen Geno-Immune Medical Institute

Azonosító

NCT04429451

A regiszteradat frissítve

2026. október 30.

Eredeti leírás

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of PSMA-specific CAR-T cell therapy in patients with PSMA positive tumor. Another goal of the study is to learn more about the function of the PSMA CAR-T cells and their persistency in the patients.A teljes eredeti leírásKevesebb

Phase I/II Clinical Trial of 4SCAR-PSMA T Cell Therapy Targeting PSMA Positive Malignancies

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of PSMA-specific CAR-T cell therapy in patients with PSMA positive tumor. Another goal of the study is to learn more about the function of the PSMA CAR-T cells and their persistency in the patients.

Bevonási feltételek: Patients with tumors have received standard first-line therapy and have been judged to be non-respectable, metastatic, progressive or recurrent; The expression status of PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses; Body weight greater than or equal to 10 kg; Age: ≥1 year and ≤ 75 years of age at the time of enrollment; Life expectancy: at least 8 weeks; Prior Therapy:; There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less; Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection; At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic non-myelosuppressive regimen; At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody; At least 1 week since any radiation therapy at the time of study entry; Karnofsky/jansky score of 60% or greater; 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); Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease does not have hematologic toxicity; For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent.

Kizáró feltételek: Untreatable central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible; Previous treatment with other genetically engineered PSMA-specific CAR T cells or antibody therapy; Patients who require systemic corticosteroid or other immunosuppressive therapy; Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity; Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection; Evidence of tumor potentially causing airway obstruction; Inability to comply with protocol requirements; Insufficient CAR T cells availability.

ClinicalTrials.gov NCT04429451