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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05868083
Other study ID # SNC-109-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 24, 2022
Est. completion date August 2024

Study information

Verified date May 2023
Source Shanghai Simnova Biotechnology Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single arm clinical study to estimate the safety, tolerability and pharmacokinetic (PK) characteristics of Chimeric Antigen Receptor-modified T cells (CAR-T) SNC-109 in patients with recurrent glioblastoma (r-GBM) and preliminarily evaluate the effectiveness, the immunogenicity of the product, as well as their correlation between the changes of cytokines from baseline level after cellular infusion.


Description:

It is planned to recruit about 16 patients with rGBM subjects. The protocol consists of screening period, Lymphocytes apheresis period, Operation period, pre-infusion evaluation (-2~-1 days), infusion (day 0), infusion observation (day 1-post infusion), and follow-up period (last infusion-720 days). The incidence of dose limitation toxicity (DLT) will be observed within 28 days after the first infusion. Subjects in this study will receive multiple infusions, starting with 2×104 CAR+ T cells/dose in the first subject, and the Safety Review Committee (SRC) will evaluate the subsequent dosing regimen, dose, infusion interval, and number of treatment cycles. Subsequent subjects will be evaluated by the SRC on the basis of available PK and safety data, and the SRC will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date August 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Age =18 and =70,both sexes; - Diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma World Health Organization (WHO) Grade 4); - Karnofsky (KPS) =60; - The estimated survival time is =8 weeks; - Blood pregnancy tests for women of childbearing age are negative; - The patient himself/herself, and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form. Exclusion Criteria: - Known allergies to study drugs or drugs that may be used in the study; - Severe concurrent diseases in the heart, lungs, liver, or other vital organs; - Hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy; - In addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies; - Long-term use of immunosuppressant drugs, or large doses of steroids; - Received live or attenuated vaccine or other surgery had no related to GBM within 4 weeks prior to Lymphocytes apheresis; - Lymphocytes apheresis or cell infusion combined with infection or unexplained fever.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SNC-109 CAR-T Cells
SNC-109 CAR-T Cells, first dose from 2×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC

Locations

Country Name City State
China Chinese PLA General Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Simnova Biotechnology Co.,Ltd. Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment related adverse everts Incidence of adverse events associated with CAR-T cell transfusion within 28 days of the first infusion, abnormal and clinical significant laboratory results Up to 28 days after first infusion
Primary Cmax of SNC-109 Cell count SNC-109 cell count maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF) within 2 years after first infusion
Primary Tmax of SNC-109 Cell count SNC-109 cell count time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF) within 2 years after first infusion
Primary AUC of SNC-109 Cell count SNC-109 cell count area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF) within 2 years after first infusion
Primary Cmax of SNC-109 CAR vector copy number SNC-109 CAR vector copy number (VCN) maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF) within 2 years after first infusion
Primary Tmax of SNC-109 CAR vector copy number SNC-109 CAR vector copy number (VCN) time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF) within 2 years after first infusion
Primary AUC of SNC-109 CAR vector copy number SNC-109 CAR vector copy number (VCN) area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF) within 2 years after first infusion
Primary Other relevant PK parameters Other relevant PK parameters in peripheral blood (PB) and cerebrospinal fluid (CSF) within 2 years after first infusion
Secondary Objective response rate (ORR) after infusion The data of objective response rate (ORR) after infusion within 2 years after first infusion
Secondary Progression free survival (PFS) after infusion The data of Progression free survival (PFS) after infusion within 2 years after first infusion
Secondary Overall survival (OS) after infusion The data of Overall survival (OS) after infusion within 2 years after first infusion
Secondary Efficacy assesment for the treatment according to iRANO Assessment of disease response rates according to the Immunological Response Assessment in Neuro-Oncology (iRANO) within 2 years after first infusion
Secondary Changes of Cytokines after infusion Changes of cytokines (such as Interleukin-6, Interleukin-8 etc.) in peripheral blood (PB) and cerebrospinal fluid (CSF) pre-and post- infusion and at each of the main follow-up time points, and the time to recovery within 2 years after first infusion
Secondary Concentration of Human anti-chimeric antibody (HACA) Detection of changes in peripheral blood and cerebrospinal fluid Human anti-chimeric antibody (HACA) within 2 years after first infusion
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