Trial Title:
TAA06 Injection in the Treatment of Patients With B7-H3-positive Relapsed/ Refractory Neuroblastoma
NCT ID:
NCT05562024
Condition:
B7-H3-positive Relapsed/ Refractory Neuroblastoma
Conditions: Official terms:
Neuroblastoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single group of qualified subjects used TAA06 injection
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
T cell injection targeting B7-H3 chimeric antigen receptor
Description:
The subjects will be administered once.
Arm group label:
T cell injection targeting TAA06 chimeric antigen receptor
Other name:
TAA06 Injection
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.
Detailed description:
In the dose-escalation phase of the Phase I clinical trial, a traditional 3+3 trial
design was adopted, with a total of 3 dose groups designed. The dose of T/kg was
gradually increased, and a total of 12-18 subjects with relapsed/refractory neuroblastoma
were enrolled.Within each dose group, the next subject can be dosed after the previous
subject has completed at least 14 days of safety observations. After the last subject of
each dose group completed the dose-limited toxicity (DLT) evaluation within 28 days after
a single dose, the SMC (Safety Monitoring Committee) agreed to enter the next dose group
after evaluating the clinical safety data. After that, the enrolment treatment for the
next dose group can be started.When 1 DLT occurs in 3 subjects in a dose group, 3
additional subjects in the same dose group (up to 6 subjects in this dose group complete
the DLT assessment): If the additional 3 subjects If no DLT occurs, continue dose
escalation; if 1 out of 3 additional subjects develops DLT, stop dose escalation; if >
1 of 3 additional subjects develops DLT DLT, then stop the dose escalation, and at the
same time need to reduce a dose to continue to enroll 3 subjects for DLT evaluation.
In the dose expansion phase of the Phase I clinical trial, SMC will review the obtained
safety and available data on efficacy, PK, immunogenicity, etc., and give the RP2D dose
after comprehensive evaluation. In the dose expansion phase, the RP2D dose group will
continue to be enrolled 3 ~6 subjects, further clarify the preliminary efficacy and
safety of RP2D.
Criteria for 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 chemotherapeutic drugs, including alkylating agents
and platinum)
- The tumor tissue samples of the subjects were stained by immunohistochemistry (IHC)
to show that the expression intensity of B7-H3 on the surface of tumor cell
membranes was 1+ or above, and the proportion of positive staining of tumor cell
membranes was ≥1%
- At least one measurable lesion defined by RECISTv1.1 criteria, and at least one
lesion that can be irradiated (except bone marrow)
- Subjects with lesions only in the bone marrow may also be enrolled (without
irradiation)
- Liver and kidney function, cardiopulmonary function must meet the following
requirements:
1. Total bilirubin ≤ 3 × ULN;ALT and AST ≤ 5 × ULN
2. Creatinine≤2 ULN
3. Left ventricular ejection fraction ≥ 50%
4. Blood oxygen saturation ≥ 92%
- Patients and/or their guardians understand the trial and have signed informed
consent
Exclusion Criteria:
- 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
- Serious cardiac disease: including but not limited to unstable angina, myocardial
infarction (within 6 months prior to screening), congestive heart failure (New York
Heart Association [NYHA] classification ≥ grade III), severe arrhythmia
- Unstable systemic disease as judged by the investigator: including but not limited
to severe liver, kidney or metabolic disease requiring drug therapy
- Presence of chronic progressive neurological disease
- Patients who have not recovered from acute toxic effects of prior treatment
- Active or uncontrolled infection requiring systemic treatment (except mild
urogenital and upper respiratory tract infections)
- Pregnancy-capable female subjects who plan to become pregnant within 2 years of cell
reinfusion; or male subjects whose partners plan to become pregnant within 2 years
of cell reinfusion
- Those who have received CAR-T therapy or other gene-modified cell therapy before
screening
- Participated in other clinical studies within 1 month before screening
- Subjects screened for evidence of central nervous system involvement
- For patients with liver metastases, the distribution of liver metastases exceeds 1/2
of the liver
- According to the judgment of the investigators, it does not meet the situation of
cell preparation
- Other circumstances deemed inappropriate by investigators
Gender:
All
Minimum age:
1 Year
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital and Institute
Address:
City:
Jinan
Zip:
250000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jingfu Wang, Doctor
Phone:
86-13821271562
Email:
wangjingfu666@163.com
Investigator:
Last name:
Jingfu Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Zhao, Doctor
Phone:
86-18622221005
Email:
qiangzhao169@aliyun.com
Investigator:
Last name:
Qiang Zhao, Doctor
Email:
Principal Investigator
Start date:
December 30, 2022
Completion date:
February 18, 2039
Lead sponsor:
Agency:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Source:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05562024
