Clinical trial · Interventional
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNC-109 CAR-T Cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SNC-109 CAR-T Cells
- description
- After the operation and pre-infusion evaluation, SNC-109 CAR-T Cells will be evaluated.
- interventionNames
- Drug: SNC-109 CAR-T Cells
Primary outcomes (8)
- measure
- Incidence of treatment related adverse everts
- timeFrame
- Up to 28 days after first infusion
- description
- Incidence of adverse events associated with CAR-T cell transfusion within 28 days of the first infusion, abnormal and clinical significant laboratory results
- measure
- Cmax of SNC-109 Cell count
- timeFrame
- within 2 years after first infusion
- description
- SNC-109 cell count maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available