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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
T cell injection targeting B7-H3 chimeric antigen receptor
Biological/VaccineThe subjects will be administered once.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: T cell injection targeting TAA06 chimeric antigen receptorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MTD
Maximum tolerated dose of TAA06 Injection in subjects with relapsed/refractory neuroblastoma
Time frame
about 3 years2
RP2D
Phase 2 recommended dose of TAA06 Injection in subjects with relapsed/refractory
Time frame
about 3 years3
Assessment of the safety after B7-H3-targeted chimeric antigen receptor T cells infusion (Safety)
Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) ,(according to the evaluation criteria for common adverse events, NCICTCAE version 5.0)
Time frame
about 3 yearsSecondary outcomes
1
Assessment of pharmacokinetic (about Cmax)
Assessment of the highest concentration (Cmax) of B7-H3-targeted chimeric antigen receptor T cells amplified in peripheral blood after administration.
Time frame
about 3 years2
Assessment of pharmacokinetic (about Tmax)
Assessment of the time to reach the highest concentration (Tmax) of B7-H3-targeted chimeric antigen receptor T cells amplified in peripheral blood after administration.
Time frame
about 3 years3
Assessment of pharmacokinetic (about AUC0-28d)
Assessment of the area under the curve AUC0-28d after administration.
Time frame
about 3 years4
Assessment of pharmacokinetic (about AUC0-90d)
Assessment of the area under the curve AUC0-90d after administration.
Time frame
about 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Source ClinicalTrials.gov