The Safety Study of Autologous TILs Therapy for Patients With Glioblastoma Multiforme.

Early Phase 1

Recruiting

• Conditions: Glioblastoma Multiforme, Adult
• Interventions: Biological: Tumor Infiltrating Lymphocytes (TIL)

• Registration Number: NCT05333588
• Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary

The study is to evaluate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy for patients with maligant glioblastoma multiforme. Autologous TiLs should be given by intravenous infusion after 5 days of lymphodepletion treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Status Verified: 2022-04
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2024-02-15
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age: 18 to 80 years old;

2. Has at least one measurable tumor foci;

3. ECOG score range : 0-2;

4. Expected survival time: ≥ 3 months;

5. All screening labs should be performed 7 days prior to registration.The laboratory results need to meet below criteria:

   • Absolute white blood cell counts (WBC) ≥ 3.0×10^9/L；
   • Platelet count (PLT) ≥ 100×10^9/L；
   • Hematological Absolute neutrophil count (ANC) ≥ 1.5×10^9/L；
   • Hemoglobin (HGB) ≥ 90g/L;
   • Albumin (absolute) ≥ 2.8g/dL;
   • Serum ALT/AST ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
   • Total bilirubin (TBIL) ≤ 1.5×ULN (for patients with liver metastasis ≤ 2×ULN);
   • Renal Serum creatinine OR measured or calculated a creatinine clearance (CR) ≤1.5×ULN OR≥ 50 mL/min for participant;
   • AST/ALT (SGOT) ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
   • International Normalized Ratio (INR) ≤ 1.5;
   • Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN;

6. Female participant of childbearing potential should have a negative result of human chorionic gonadotropin (HCG) test. The participants must take contraception during the entire clinical follow-up.

7. Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria

1. Has systemic active infection and requiring treatment;

2. Has severe physical or mental illness;

3. Has active rheumatic disease;

4. Has any kinds of organ transplantation;

5. Being pregnant or lactating;

6. Enrolled in other clinical trials within 4 weeks prior to registration;

7. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C;

8. Other conditions that the researcher considered to be excluded;

9. Has taken blow treatment before enrollment:

   • Received systemic immunosuppressive treatments, aside from corticosteroids within 14 days of treatment;
   • Plan to get inactivated vaccine 28 days prior/during, or 60 days post the treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor infiltrating lymphocyte	Tumor Infiltrating Lymphocytes (TIL)	1x10\^9-5x10\^10 of autologous TILs will be adoptive transfer to patients.

Primary Outcome Measures

Name	Time	Method
Number of adverse events related to TiLs infusion	1 month	The primary outcome measure of this clinical trial is accessed by the safety of the TILs product. The safety profile for TILs is characterized by its incidence of the adverse events.

Secondary Outcome Measures

Name	Time	Method
Progressional free of survival (PFS)	Up to 24 months	PFS is defined as the duration of time from start of treatment to time of progression. All patients will be followed for a minimum of 2 years.
Objective response rate (ORR)	24 months

Trial Locations

Locations (1)

The Second Hospital of HeBei Medical University; 🇨🇳 Shijiazhuang, Hebei, China