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

NCT05868083 | Unknown Phase 1

• 1 other identifier: SNC-109-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Glioblastoma Multiforme

Keywords

CAR-T; GBM

Outcome Measures

Primary Outcomes (8)

• Incidence of treatment related adverse everts

  Incidence of adverse events associated with CAR-T cell transfusion within 28 days of the first infusion, abnormal and clinical significant laboratory results

  Up to 28 days after first infusion

• Cmax of SNC-109 Cell count

  SNC-109 cell count maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)

  within 2 years after first infusion

• Tmax of SNC-109 Cell count

  SNC-109 cell count time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)

  within 2 years after first infusion

• AUC of SNC-109 Cell count

  SNC-109 cell count area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF)

  within 2 years after first infusion

• Cmax of SNC-109 CAR vector copy number

  SNC-109 CAR vector copy number (VCN) maximum (Cmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)

  within 2 years after first infusion

• Tmax of SNC-109 CAR vector copy number

  SNC-109 CAR vector copy number (VCN) time to Cmax(Tmax) in peripheral blood (PB) and cerebrospinal fluid (CSF)

  within 2 years after first infusion

• AUC of SNC-109 CAR vector copy number

  SNC-109 CAR vector copy number (VCN) area under the curve (AUC) in peripheral blood (PB) and cerebrospinal fluid (CSF)

  within 2 years after first infusion

• Other relevant PK parameters

  Other relevant PK parameters in peripheral blood (PB) and cerebrospinal fluid (CSF)

  within 2 years after first infusion

Secondary Outcomes (6)

• Objective response rate (ORR) after infusion

  within 2 years after first infusion

• Progression free survival (PFS) after infusion

  within 2 years after first infusion

• Overall survival (OS) after infusion

  within 2 years after first infusion

• Efficacy assesment for the treatment according to iRANO

  within 2 years after first infusion

• Changes of Cytokines after infusion

  within 2 years after first infusion

Study Arms (1)

SNC-109 CAR-T Cells

EXPERIMENTAL

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

Drug: SNC-109 CAR-T Cells

Interventions

SNC-109 CAR-T Cells 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

SNC-109 CAR-T Cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Simnova Biotechnology Co.,Ltd.: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 22, 2023
• Study Start: June 24, 2022
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 23, 2024

Record last verified: 2023-05

Locations

CN (1)