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Trial Title:
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM
NCT ID:
NCT06616727
Condition:
Recurrent Glioblastoma Multiforme (GBM)
Conditions: Official terms:
Glioblastoma
Conditions: Keywords:
GBM
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SNC109
Description:
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
Arm group label:
SNC109 CART
Summary:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Country:
China
Start date:
December 26, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shanghai Simnova Biotechnology Co.,Ltd.
Agency class:
Industry
Source:
Shanghai Simnova Biotechnology Co.,Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06616727
