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

NCT ID: NCT05868083

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-24
• Study Completion Date: 2024-08-31

Brief 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.

Detailed Description

It is planned to recruit about 16 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 2×104 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

Study Design

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

Study Groups

SNC-109 CAR-T Cells

After the operation and pre-infusion evaluation, SNC-109 CAR-T Cells will be evaluated.

Group Type: EXPERIMENTAL

SNC-109 CAR-T Cells

Intervention Type: DRUG

SNC-109 CAR-T Cells, first dose from 2×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC

Interventions

SNC-109 CAR-T Cells

SNC-109 CAR-T Cells, first dose from 2×104 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Shanghai Simnova Biotechnology Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese PLA General Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ling Chen

Role: primary

chen_ling301@163.com

8610-66887329

Other Identifiers

SNC-109-101

Identifier Type: -

Identifier Source: org_study_id