Tests GD2/PSMA CAR-T cell therapy in people with solid tumors
Tests modified immune cells targeting GD2 and PSMA in people with solid tumors.
Plain-language title generated from the registry record
Registry title: GD2/PSMA Bi-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 with a solid tumor that tests positive for GD2 or PSMA, that has spread, grown or come back, and that cannot be removed by surgery, after standard first-line treatment.
- Age
- 1 year to 75 years
- Sex
- All sexes
- Disease stage
- Solid tumor that cannot be removed by surgery, has spread, is getting worse or has come back, after standard first-line therapy.
- Earlier treatment
- Must have had standard first-line therapy. There is no limit on the number of earlier treatments. At least 4 weeks since a monoclonal antibody, 7 days since a biologic or targeted agent, 1 week since radiation. Cannot have had earlier GD2 or PSMA CAR T cells or antibody therapy.
- Biomarker or test result
- Tumor tissue must test positive for GD2 or PSMA (checked by immunohistochemistry or flow cytometry).
Main reasons for not taking part
- Severe illness or major organ problems, such as heart, lung or liver disease
- Brain or spinal cord (CNS) tumor spread that cannot be treated
- Earlier GD2 or PSMA CAR T cells or antibody therapy
- Active HIV, hepatitis B, hepatitis C or uncontrolled infection
- Needing steroids or other drugs that weaken the immune system
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: NCT05437315, 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
- NCT05437315
- Record updated
- 2 November 2026
- Original description
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/PSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor. Another goal of the study is to learn more about the function of the anti-GD2/PSMA bi-specific CAR-T cells and their persistency in patients.Read full original descriptionShow less
GD2/PSMA Bi-specific CAR-T Cells For the Treatment of GD2 and PSMA Positive Solid Tumors
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/PSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor. Another goal of the study is to learn more about the function of the anti-GD2/PSMA bi-specific CAR-T cells and their persistency in patients.
Inclusion: Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent; The expression status of GD2 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and 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 be 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, selected targeted agent 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 GD2 or 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.