TH-CAR-027 for Grade 4 Gliomas
ConditionR/R Grade 4 Glioma
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Tongji Hospital, Tongji University School of Medicine
About this trial
This is an open-Label, dose-escalation, multiple administration, exploratory clinical study to evaluate the safety, tolerability, and anti-tumor activity of TH-CART-027 cell injection in subjects with recurrent or progressive grade 4 glioma
Eligibility criteria
Qualifiers
1. Voluntarily participate in the clinical trial; fully understand and are informed about this study and sign the informed consent form; willing and able to comply with and complete all trial procedures.
Hematological Function: Absolute neutrophil count (ANC)≥1.5×10^9/L, hemoglobin ≥90 g/L, platelet count≥100×10^9/L, absolute lymphocyte count≥0.15×10^9/L. No transfusion,granulocyte (macrophage)colony-stimulating factor, recombinant human erythropoietin, recombinant human thrombopoietin, thrombopoietin receptor agonist, recombinant human interleukin-11, or other supportive therapy within 14 days prior to the test.
Liver Function: Total bilirubin≤1.5×upper limit of normal (ULN) (except for patients with Gilbert's syndrome characterized by persistent or recurrent unconjugated hyperbilirubinemia in the absence of hemolysis or hepatic pathology); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN.
Renal Function: Serum creatinine ≤1.5×ULN.
Disqualifiers
Seropositivity for HIV antibody or positive serological test for Treponema pallidum (syphilis).
Hepatitis B surface antigen (HBsAg) positivity with peripheral blood HBV DNA levels above the upper limit of normal.
Hepatitis C virus (HCV) antibody positivity with detectable peripheral blood HCV RNA.
Having undergone carmustine wafer implantation surgery within the past 6 months.
Trial design
Treatments tested in this trial
- TH-CART-027
Treatment groups
21 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov