NCT06616727Enrolling by invitationPhase 1
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
Source: ClinicalTrials.gov · Last updated 27 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Sept 2024
- Start date
- 26 Dec 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.
- Diseases
- Glioblastoma
- NCT number
- NCT06616727
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From 26 Dec 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concurrent diseases in the heart, lungs, liver, or other vital organs;
- Long-term use of immunosuppressant drugs, or large doses of steroids;
Other illness
- Known allergies to study drugs or drugs that may be used in the study;
- 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;
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.