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

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Simnova Biotechnology Co.,Ltd.
• Collaborator: Chinese PLA General Hospital

Criteria

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.