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

NCT ID: NCT06616727

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-26
• Study Completion Date: 2026-12-31

Brief Summary

A phase I study to evaluate the safety, tolerance and pharmacokinetics of SNC109 in patients with rGBM

Detailed Description

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 regimen, dose, infusion interval, and number of treatment cycles. Subsequent subjects will be evaluated by the SRC on the basis of available PK and safety data, and the SRC will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.

Conditions

Recurrent Glioblastoma Multiforme (GBM)

Keywords

GBM

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SNC109 CART

After the screening and evaluation, SNC-109 CAR-T Cells will be infusion.

Group Type: EXPERIMENTAL

SNC109

Intervention Type: DRUG

SNC-109 CAR-T Cells, first dose from 5×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC

Interventions

SNC109

SNC-109 CAR-T Cells, first dose from 5×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Simnova Biotechnology Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese PLA General Hospital

Beijing, , China

Countries

China

Other Identifiers

SNC109-102

Identifier Type: -

Identifier Source: org_study_id