Back to resultsThe Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma
Primary Purpose
Recurrent Glioblastoma Multiforme
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SNC-109 CAR-T Cells
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Glioblastoma Multiforme focused on measuring CAR-T, GBM
Eligibility Criteria
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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SNC-109 CAR-T Cells
Arm Description
After the operation and pre-infusion evaluation, SNC-109 CAR-T Cells will be evaluated.
Outcomes
Primary Outcome Measures
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
Cmax of SNC-109 Cell count
SNC-109 cell count maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)
Tmax of SNC-109 Cell count
SNC-109 cell count time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)
AUC of SNC-109 Cell count
SNC-109 cell count area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF)
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)
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)
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)
Other relevant PK parameters
Other relevant PK parameters in peripheral blood (PB) and cerebrospinal fluid (CSF)
Secondary Outcome Measures
Objective response rate (ORR) after infusion
The data of objective response rate (ORR) after infusion
Progression free survival (PFS) after infusion
The data of Progression free survival (PFS) after infusion
Overall survival (OS) after infusion
The data of Overall survival (OS) after infusion
Efficacy assesment for the treatment according to iRANO
Assessment of disease response rates according to the Immunological Response Assessment in Neuro-Oncology (iRANO)
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
Concentration of Human anti-chimeric antibody (HACA)
Detection of changes in peripheral blood and cerebrospinal fluid Human anti-chimeric antibody (HACA)
Full Information
NCT ID
NCT05868083
First Posted
April 18, 2023
Last Updated
May 11, 2023
Sponsor
Shanghai Simnova Biotechnology Co.,Ltd.
Collaborators
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05868083
Brief Title
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma
Official Title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SNC-109 CAR-T Cell Therapy in Subjects With Recurrent Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Simnova Biotechnology Co.,Ltd.
Collaborators
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma Multiforme
Keywords
CAR-T, GBM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SNC-109 CAR-T Cells
Arm Type
Experimental
Arm Description
After the operation and pre-infusion evaluation, SNC-109 CAR-T Cells will be evaluated.
Intervention Type
Drug
Intervention Name(s)
SNC-109 CAR-T Cells
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of treatment related adverse everts
Description
Incidence of adverse events associated with CAR-T cell transfusion within 28 days of the first infusion, abnormal and clinical significant laboratory results
Time Frame
Up to 28 days after first infusion
Title
Cmax of SNC-109 Cell count
Description
SNC-109 cell count maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)
Time Frame
within 2 years after first infusion
Title
Tmax of SNC-109 Cell count
Description
SNC-109 cell count time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)
Time Frame
within 2 years after first infusion
Title
AUC of SNC-109 Cell count
Description
SNC-109 cell count area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF)
Time Frame
within 2 years after first infusion
Title
Cmax of SNC-109 CAR vector copy number
Description
SNC-109 CAR vector copy number (VCN) maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)
Time Frame
within 2 years after first infusion
Title
Tmax of SNC-109 CAR vector copy number
Description
SNC-109 CAR vector copy number (VCN) time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)
Time Frame
within 2 years after first infusion
Title
AUC of SNC-109 CAR vector copy number
Description
SNC-109 CAR vector copy number (VCN) area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF)
Time Frame
within 2 years after first infusion
Title
Other relevant PK parameters
Description
Other relevant PK parameters in peripheral blood (PB) and cerebrospinal fluid (CSF)
Time Frame
within 2 years after first infusion
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) after infusion
Description
The data of objective response rate (ORR) after infusion
Time Frame
within 2 years after first infusion
Title
Progression free survival (PFS) after infusion
Description
The data of Progression free survival (PFS) after infusion
Time Frame
within 2 years after first infusion
Title
Overall survival (OS) after infusion
Description
The data of Overall survival (OS) after infusion
Time Frame
within 2 years after first infusion
Title
Efficacy assesment for the treatment according to iRANO
Description
Assessment of disease response rates according to the Immunological Response Assessment in Neuro-Oncology (iRANO)
Time Frame
within 2 years after first infusion
Title
Changes of Cytokines after infusion
Description
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
Time Frame
within 2 years after first infusion
Title
Concentration of Human anti-chimeric antibody (HACA)
Description
Detection of changes in peripheral blood and cerebrospinal fluid Human anti-chimeric antibody (HACA)
Time Frame
within 2 years after first infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Chen
Phone
8610-66887329
Email
chen_ling301@163.com
First Name & Middle Initial & Last Name & Degree
Ling Chen, MD/PhD
12. IPD Sharing Statement
Learn more about this trial
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma
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