CAR-T cell therapy for tumors that carry the PSMA protein
Tests modified immune T cells against PSMA-positive tumors in people aged 1 to 75.
Plain-language title generated from the registry record
Registry title: PSMA-specific CAR-T Cell Therapy
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 1 to 75 whose tumor has PSMA on its cells. Their cancer must have come back, grown, or spread after standard first treatment.
- Age
- 1 year to 75 years
- Sex
- All sexes can join.
- Disease stage
- Tumor that cannot be removed by surgery, has spread, is getting worse, or has come back after standard first-line treatment.
- Earlier treatment
- Standard first-line therapy is required. There is no limit on how many treatments were tried before. Waiting times apply after some treatments, such as 4 weeks after a monoclonal antibody and 1 week after radiation.
- Biomarker or test result
- The tumor tissue must be positive for PSMA, shown by antibody staining (immunohistochemistry or flow cytometry).
Main reasons for not taking part
- Severe illness or major organ problems
- Brain or spinal cord (CNS) tumor spread that cannot be treated
- Earlier treatment with PSMA-specific CAR T cells or antibody therapy
- Active HIV, hepatitis B, hepatitis C or uncontrolled infection
- Need for steroid or other immune-suppressing medicine
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 75 years old?
Source: NCT04429451, who can take part
Where in China
- Shenzhen Geno-immune Medical InstituteShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Geno-Immune Medical Institute
- Trial code
- NCT04429451
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.