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

NCT06616727 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: SNC109-102
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Glioblastoma Multiforme (GBM)

Keywords

GBM

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment related adverse events

  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

• DLT

  Incidence of DLT associated with CAR-T cell transfusion within 28 days of the first infusion

  Up to 28 days after first infusion

Secondary Outcomes (8)

• Overall survival (OS) after infusion

  within 2 years after first infusion

• Time maximum of SNC-109 Cell count and CAR vector copy number

  within 2 years after first infusion

• Pharmacokinetic (PK) profile/parameters Peak Plasma Concentration (Cmax) of SNC-109 Cell count and CAR vector copy number

  within 2 years after first infusion

• Pharmacokinetic (PK) profile/parameters Area under the plasma concentration versus time curve (AUC)

  within 2 years after first infusion

• Progression free survival (PFS) after infusion

  within 2 years after first infusion

Study Arms (1)

SNC109 CART

EXPERIMENTAL

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

Drug: SNC109

Interventions

SNC109 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

SNC109 CART

Eligibility Criteria

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

You may qualify if:

• 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.

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

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

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: September 2, 2024
• First Posted: September 27, 2024
• Study Start: December 26, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CN (1)