Clinical Study on Evaluation of Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T Cell Injection in Treatment of Advanced Glioma

Second Affiliated Hospital of Soochow University1 site in 1 country12 target enrollmentMay 1, 2021

ConditionsAdvanced Glioma Complication of Chimeric Antigen Receptor (CAR-T) Cell Therapy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Advanced Glioma
Sponsor: Second Affiliated Hospital of Soochow University
Enrollment: 12
Locations: 1
Primary Endpoint: Objective Response Rate
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to estimate the safety, tolerance and initial efficacy of target IL-13Rα2 or B7-H3 UCAR-T cell injection in the treatment of patients with advanced glioma, as well as the pharmacokinetic characteristics of its metabolites after single and multiple administrations and the biomarkers related to efficacy, safety and drug metabolism.

Registry

clinicaltrials.gov

Start Date

May 1, 2021

End Date

April 30, 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Second Affiliated Hospital of Soochow University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18-70 years old, male or female, and the expected survival period is not less than 3 months.
•Advanced, locally advanced or recurrent tumor diagnosed histologically or cytologically.
•Failed in previous standard treatment or gived up treatment for various reasons after failure of first-line treatment.
•Failed in therapy by PD-1 or PD-L1 antibody or stopped administration of PD-1 or PD-L1 antibody for more than 4 weeks.
•At least 1 measurable target lesion (RECIST v1.1).
•0-2 in ECOG physical state score.
•Available initial or recurrent tumor tissue for at least 10 stanable and detectable sections.
•Blood routine test: WBC ≥ 3×10\^9/L, lymphocyte percentage (LY%) ≥ 15%, hemoglobin Hbo (Hb) ≥ 90g/L, platelet (PLT) ≥ 60×10\^9/L.
•Liver and kidney functions: alanine transaminase (ALT) and aspartate transaminase (AST) \< 3 times of the normal value, total bilirubin (TBiL) \< 1.5 times of the normal value, serum creatinine (SCR) \< 1.5 times of the normal value.
•IL-13Rα2 or B7-H3 antigen expression \> 50%.

Exclusion Criteria

•Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer ≥ 5 × 10\^2 copies/L; HCV antibody and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; CMV DNA test positive; Syphilis test positive.
•Experienced any gene therapy previously.
•Needing long-term immunosuppressants for any reason.
•Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis.
•Severe heart, lung, liver and kidney insufficiency or severe debilitating lung disease; Cardiac function: Grade III or above according to NYHA standard; Liver function: grade C in Child-Puge grading standard; Renal function: chronic kidney disease (CKD) more than stage 4; Renal insufficiency above stage Ⅲ; Lung function: symptoms of severe respiratory failure, involving other organs; Brain function: abnormality of central nervous system or disturbance of consciousness.
•Administrating of systematical steroids currently (except usage inhaled steroids recently or currently).
•Pregnancy and lactation (the safety of this treatment for unborn children is not clear, and female participants with reproductive potential must have negative serum or urine pregnancy test within 48 hours before administration).
•Allergy to immunotherapy and related drugs.
•Complicated with another tumor.
•History of organ transplantation or waiting for organ transplantation.