NCT04637503 4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma
| NCT ID | NCT04637503 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2026-06-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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: 1. 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. 2. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 3. 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. 4. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 5. 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 Criteria: * Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity. * 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. * Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection. * Patients who require systemic corticosteroid or other immunosuppressive therapy. * Evidence of tumor potentially causing airway obstruction. * Inability to comply with protocol requirements. * Insufficient CART cells availability.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04637503 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 65 Years, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04637503 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04637503 currently recruiting?
Yes, NCT04637503 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT04637503 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT04637503 clinical trial?
NCT04637503 is sponsored by Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 100 participants.