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Clinical Trials in China / NCT04429451
Starting soon Phase 1/2

PSMA-specific CAR-T Cell Therapy

NCT04429451 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Geno-Immune Medical Institute
Phase
Phase 1/2
Started
2026-12-31
Last updated
2026-08-26

Condition(s) studied

PSMA Positive Tumors or Tumor Tissues

Investigational drug(s) / intervention(s)

4SCAR-PSMA T cells

4SCAR-PSMA T cells: Infusion of 4SCAR-PSMA T cells at 10\^6 cells/kg body weight via IV

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with tumors have received standard first-line therapy and have been judged to be non-respectable, metastatic, progressive or recurrent. 2. 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. 3. Body weight greater than or equal to 10 kg. 4. Age: ≥1 year and ≤ 75 years of age at the time of enrollment. 5. Life expectancy: at least 8 weeks. 6. 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. 7. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 8. 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. 9. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 10. At least 1 week since any radiation therapy at the time of study entry. 11. Karnofsky/jansky score of 60% or greater. 12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent. 13. Pulse Ox greater than or equal to 90% on room air. 14. 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. 15. Renal function: Patients must have serum creatinine less than 3 times upper limit of normal. 16. 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). 17. 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. 18. For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent. Exclusion Criteria: 1. Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity. 2. 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. 3. Previous treatment with other genetically engineered PSMA-specific CAR T cells or antibody therapy. 4. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection. 5. Patients who require systemic corticosteroid or other immunosuppressive therapy. 6. Evidence of tumor potentially causing airway obstruction. 7. Inability to comply with protocol requirements. 8. Insufficient CAR T cells availability.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shenzhen Geno-immune Medical Institute Shenzhen Guangdong

More Shenzhen Geno-Immune Medical Institute trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04429451 on ClinicalTrials.gov ↗ ← All trials in China