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Recruiting
NCT04637503
4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma
Conditions: Neuroblastoma
Sex: All
Ages: 1 Year – 65 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 100
Sponsor: Shenzhen Geno-Immune Medical Institute
Location: Shenzhen Geno-Immune Medical Institute Shenzhen Guangzhou
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) \
Source: ClinicalTrials.gov (NCT04637503). StuddyBuddy aggregates publicly available trial information.