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

Glioblastoma Multiforme, Adult Clinical Trial

Official title:

The Safety and Efficacy Study of Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy Combined With Conventional Chemotherapy for Patients With Advanced Stage of Glioblastoma Multiforme.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333588
• Other study ID #: TILs for Glioblastoma
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 15, 2022
• Est. completion date: February 15, 2025

Study information

• Verified date: April 2022
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Na Kuang
• Phone: +8618630160116
• Email: kuangna[@]senlangbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme, Adult

Intervention

Biological:
• Tumor Infiltrating Lymphocytes (TIL)
The autologous TILs will be intravenous infused into patients.

Locations

Country	Name	City	State
China	The Second Hospital of HeBei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events related to TiLs infusion	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.	1 month
Secondary	Progressional free of survival (PFS)	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.	Up to 24 months
Secondary	Objective response rate (ORR)		24 months