4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma
ConditionNeuroblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-65
SponsorShenzhen Geno-Immune Medical Institute
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GD2, PSMA and CD276 CAR-T cells
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov