TAA06 Injection in the Treatment of Patients With B7-H3-positive Relapsed/ Refractory Neuroblastoma
Trial Parameters
Brief Summary
Phase I clinical trials are designed as open-label, dose-escalation and dose-expansion clinical studies, the main purpose of which is to explore the tolerability, safety, cytokinetic characteristics and RP2D and preliminary observation of the efficacy of the study drug in subjects with B7-H3-positive relapsed/refractory neuroblastoma.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 1 year (including cut-off value), gender is not limited * Expected survival time ≥ 3 months * Karnofsky score (\> 16 years) or Lansky score (≤ 16 years) \> 60 points * Meet the clinical diagnostic criteria and be diagnosed as recurrent / refractory neuroblastoma. For first-line standard treatment, please refer to the consensus of experts in the diagnosis and treatment of Pediatric Neuroblastoma (Chinese Journal of Pediatric surgery, Volume 36, No. 1, 2015), the guidelines for the diagnosis and treatment of Pediatric Neuroblastoma of 2019 by the Health Commission, and the consensus of experts in the diagnosis and treatment of Pediatric Neuroblastoma (CCCG-NB-2021 Program) (Chinese Journal of Pediatric surgery, Volume 43, No. 7, 2022) 1. Recurrence is defined as the determination of recurrence after remission after at least first-line standard treatment. 2. Refractory is defined as a person who is not in remission after at least 4 cycles of chemotherapy (≥ 2 c