Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • TH-CART-027

    Drug

    Multiple-dosing, intratumoral and/or intraventricular infusion

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: TH-CART-027Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety：Incidence of Dose Limiting Toxicity (DLT)

Limiting toxicity type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TH-CART-027 infusion

Time frame
28 days after the first TH-CART-027 infusion
2

Safety：Incidence and severity of adverse events (AEs)

To evaluate possible adverse events after TH-CAPT-027 infusion, including the incidence and severity of AEs.

Time frame
Six months post CAR-T cells infusion.

Secondary outcomes

1

Overall survival (OS)

Time from treatment initiation to death from any cause.

Time frame
12 and 24 months post CAR-T cells infusion
2

Objective response rate (ORR)

The assessment will be based on the investigator's evaluation of imaging evaluations, with efficacy evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). ORR refers to the proportion of patients with objective evidence of achieving a Complete Response (CR) or Partial Response (PR). Where applicable, responses recorded after disease progression or initiation of non-investigational anticancer therapy will be excluded

Time frame
3 months post CAR-T cells infusion
3

Progression Free Survival (PFS)

Defined as the time from initiation of the investigational drug to the first occurrence of progressive disease (PD) or death from any cause in the absence of documented PD. If no tumor progression is observed and the subject does not die during the study period, the analysis cutoff date will be determined as the date of the last tumor assessment

Time frame
1 year post CAR-T cells infusion
4

Disease Control Rate (DCR)

Defined as the proportion of patients achieving Partial Response (PR), Complete Response (CR), or Stable Disease (SD) according to RECIST 1.1 criteria, relative to the total number of cases in the study

Time frame
1 year post CAR-T cells infusion

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Tongji Hospital, Tongji University School of Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: