The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SNC109.
- Who it may be relevant to
- Registry conditions: Recurrent Glioblastoma Multiforme (GBM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma
Overview
A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM
Detailed description
It is planned to recruit about 50 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 5×104 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.
Interventions
- Drug SNC109
SNC-109 CAR-T Cells, first dose from 5×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC
Primary outcome measures
- Incidence of treatment related adverse events [Time frame: Up to 28 days after first infusion]
- DLT [Time frame: Up to 28 days after first infusion]
Secondary outcome measures (8)
- Overall survival (OS) after infusion [Time frame: within 2 years after first infusion]
- Time maximum of SNC-109 Cell count and CAR vector copy number [Time frame: within 2 years after first infusion]
- Pharmacokinetic (PK) profile/parameters Peak Plasma Concentration (Cmax) of SNC-109 Cell count and CAR vector copy number [Time frame: within 2 years after first infusion]
- Pharmacokinetic (PK) profile/parameters Area under the plasma concentration versus time curve (AUC) [Time frame: within 2 years after first infusion]
- Progression free survival (PFS) after infusion [Time frame: within 2 years after first infusion]
- Efficacy assesment for the treatment according to iRANO [Time frame: within 2 years after first infusion]
- Pharmacodynamic (PD) profile/parameters Changes of Cytokines after infusion [Time frame: within 2 years after first infusion]
- Concentration of Human anti-chimeric antibody (HACA) [Time frame: within 2 years after first infusion]
Eligibility criteria
Inclusion criteria
- Age ≥18，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) ≥50;
- The estimated survival time is ≥12 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT06616727 · SNC109-102