TAA06 Injection in the Treatment of Patients With B7-H3-positive Relapsed/ Refractory Neuroblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1+
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.
About this trial
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
Qualifiers
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)
Disqualifiers
Patients who were judged by the investigator to require long-term immunosuppressive therapy at the time of screening
Cerebrovascular accident or seizure occurred within 6 months before signing the informed consent
Malignant tumors other than neuroblastoma, excluding carcinoma in situ
Hepatitis B surface antigen (HBsAg) positive; hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood type C Hepatitis virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive
Trial design
Treatments tested in this trial
- T cell injection targeting B7-H3 chimeric antigen receptor
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Source ClinicalTrials.gov