Clinical trial · Interventional
The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma
NCT06616727CI-TRIAL-00081147enrolling by invitationPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM
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 (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNC109 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SNC109 CART
- description
- After the screening and evaluation, SNC-109 CAR-T Cells will be infusion.
- interventionNames
- Drug: SNC109
Primary outcomes (2)
- measure
- Incidence of treatment related adverse events
- 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
- DLT
- timeFrame
- Up to 28 days after first infusion
- description
- Incidence of DLT associated with CAR-T cell transfusion within 28 days of the first infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.