Recurrent Glioblastoma Multiforme Clinical Trial
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
Verified date | May 2023 |
Source | Shanghai Simnova Biotechnology Co.,Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Shanghai Simnova Biotechnology Co.,Ltd. | Chinese PLA General Hospital |
China,
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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