The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM

Study Purpose

A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06616727
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shanghai Simnova Biotechnology Co.,Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent Glioblastoma Multiforme (GBM)

Additional Details

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.

Arms & Interventions

Arms

Experimental: SNC109 CART

After the screening and evaluation, SNC-109 CAR-T Cells will be infusion.

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

Contact a Trial Team

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International Sites

Chinese PLA General Hospital, Beijing, China

Status

Address

Chinese PLA General Hospital

Beijing, ,

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