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Study identifier: NCT06836505 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Safety and Efficacy of CAR-T Cell Therapy for Relapsed/refractory Neuroblastoma and Desmoplastic Small Round Cell Tumors: a Single-arm, Open-label Trial.

Condition: Neuroblastoma (NB) · Desmoplastic Small Round Cell Tumor (DSRCT)  ·  Sponsor: Sun Yat-Sen University Cancer Center

PhasePhase 1/Phase 2
Planned participants10
Who can joinAll sexes, 1 Year to 50 Years
Healthy volunteersNo

About this study

Title: Safety and efficacy of CAR-T cell therapy for relapsed/refractory neuroblastoma and desmoplastic small round cell tumors: a single-arm, open-label trial. The CART used in this study will be provided by Shanghai YaKe Biotechnology Ltd. Aims: 1. To evaluate the safety and efficacy of GD2/B7H3 CAR-T therapy for relapsed/refractory neuroblastoma, and observe its pharmacokinetic/pharmacodynamic characteristics and the survival of CAR-T cells in relapsed/refractory neuroblastoma patients. 2. To evaluate the safety and efficacy of GD2/B7H3 CAR-T therapy for relapsed/refractory desmoplastic small round cell tumor, and observe its pharmacokinetic/pharmacodynamic characteristics and the survival of CAR-T cells in desmoplastic small round cell tumor patients. Patients: Relapsed/refractory neuroblastoma; Relapsed/refractory desmoplastic small round cell tumor. CAR-T therapy: Lymphodepletion treatment will be performed within 14 days prior to CAR-T cell infusion: intravenous chemotherapy based on fludarabine 25mg/m² and cyclophosphamide 500mg/m² for 1 to 3 days. CAR-T cells will then be infused intravenously, with a dosage of 1.00 to 10.00 × 10⁶/kg of CAR-positive T cells. Research period: CAR-T cell infusion will be followed up for one year, or until adverse events resolve, progression occurs, or the patient transitions to other treatments. Outcome measures: Incidence of adverse events related to CAR-T therapy, as well as their intensity and duration; Pharmacokinetic/pharm…

This description comes directly from the study's public registry record.

Talk to the study team

Yizhuo Zhang, PhD  ·  020-87342460  ·  zhangyzh@sysucc.org.cn

Suying Lu, PhD  ·  lusy@sysucc.org.cn

Always discuss trial participation with your own doctor first.

Locations (3)

Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, ChinaRecruiting
Dongguan Taixin HospitalDongguan, Guang, ChinaRecruiting
Shanghai YaKe Biotechnology Ltd.Shanghai, Shanghai Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06836505