Safety and Efficacy of Targeted IL-13 Rα2 or B7-H3 UCAR-T for Advanced Glioma

Launched by SECOND AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Mar 2, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for patients with advanced glioma, a type of brain tumor. Researchers are testing a special type of cell therapy called UCAR-T, which targets specific proteins (IL-13Rα2 and B7-H3) to see if it is safe and effective for patients whose tumors have not responded to previous treatments. The study aims to understand how the body processes this treatment and to identify any biomarkers—indicators in the body that can show how well the treatment is working or how safe it is.

To participate in this trial, patients must be between 18 and 70 years old and have a diagnosis of advanced glioma that has not improved with standard treatments. They should have a measurable tumor and their overall health should be stable enough for treatment. Participants will receive injections of the UCAR-T cells and will be monitored for their safety and how well the treatment works. It's important to note that individuals with certain health conditions or those who are pregnant or breastfeeding cannot join the trial. This study is currently recruiting, so interested patients should talk to their healthcare provider for more information.

Gender

ALL

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%.
• • Volunteered to enroll this study and signed the informed consent with good compliance and cooperation with follow-up.
• • Experienced radiotherapy and chemotherapy with an interval of more than 4 week.
• 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.
• • After evaluation by researcher,noncompliance with the requirements of the study protocol was confirmed.