Search / Trial NCT06616727

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

Launched by SHANGHAI SIMNOVA BIOTECHNOLOGY CO.,LTD. · Sep 26, 2024

Trial Information

Current as of December 22, 2024

Enrolling by invitation

Keywords

Gbm

ClinConnect Summary

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...

Gender

ALL

Eligibility 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.

About Shanghai Simnova Biotechnology Co.,Ltd.

Shanghai Simnova Biotechnology Co., Ltd. is a leading biopharmaceutical company specializing in the research, development, and commercialization of innovative therapeutic solutions. With a strong focus on advancing precision medicine, Simnova integrates cutting-edge biotechnology and data analytics to address unmet medical needs across various therapeutic areas, including oncology and autoimmune diseases. Committed to enhancing patient outcomes, the company leverages its state-of-the-art facilities and a team of experienced professionals to drive clinical trials and expedite the transition of novel therapies from the laboratory to clinical practice.

Locations

Beijing, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0