CAR-T cell therapy for neuroblastoma that came back or did not respond
Tests CAR-T cells aimed at GD2, PSMA and CD276 in relapsed neuroblastoma.
Plain-language title generated from the registry record
Registry title: 4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma
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 65 with neuroblastoma that has come back or not responded, after standard first treatment. The tumor must show the GD2, PSMA and CD276 markers.
- Age
- 1 year to 65 years
- Sex
- All sexes
- Disease stage
- Neuroblastoma 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. No limit on the number of earlier treatments. Waiting times after earlier treatments apply: 7 days after targeted or biologic drugs, 4 weeks after antibody therapy, 1 week after radiation.
- Biomarker or test result
- The tumor must be positive for GD2, PSMA and CD276, shown by immunohistochemistry or flow cytometry
Main reasons for not taking part
- Severe heart, lung or liver disease or other major organ problems
- Untreated cancer spread to the brain or spinal cord
- Earlier treatment with GD2, PSMA and CD276 CAR-T cells
- Active HIV, hepatitis B or hepatitis C infection, or an infection that is not under control
- Needs steroid or other immune-suppressing treatment
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 65 years old?
Source: NCT04637503, 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
- NCT04637503
- Record updated
- 30 October 2026
- Original description
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple 4SCAR-T cell therapy which targets GD2, PSMA and CD276 surface antigens in patients with relapsed and refractory neuroblastoma (NB). Another goal of the study is to understand the function of the multi-CAR-T cells and their persistency in the patients.Read full original descriptionShow less
Multi-center Phase I/II Clinical Trial of 4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple 4SCAR-T cell therapy which targets GD2, PSMA and CD276 surface antigens in patients with relapsed and refractory neuroblastoma (NB). Another goal of the study is to understand the function of the multi-CAR-T cells and their persistency in the patients.
Inclusion: Patients with tumors have received standard first-line therapy and been judged to be non-resectable, metastatic, progressive or recurrent; The expression status of GD2, PSMA and CD276 antigens of the tumor will be determined for eligibility. Positive expression is defined by GD2, PMSA and CD276 antibody staining results based on immunohistochemistry or flow cytometry analyses; Body weight greater than or equal to 10 kg; Age: ≥1 year and ≤ 65 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 not evaluable for hematologic toxicity; For all patients enrolled in this study, their parents or legal guardians must sign an informed consent and assent.
Exclusion: Untreated 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, PSMA and CD276 CART cells; Patients who require systemic corticosteroid or other immunosuppressive therapy; Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 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 CART cells availability.