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

Hebei Senlang Biotechnology

Status and phase: Enrolling; Early Phase 1

Conditions: Glioblastoma Multiforme, Adult

Treatments: Biological: Tumor Infiltrating Lymphocytes (TIL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05333588

TILs for Glioblastoma

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Tumor infiltrating lymphocyte

Experimental group

Description:

1x10\^9-5x10\^10 of autologous TILs will be adoptive transfer to patients.

Treatment:

Biological: Tumor Infiltrating Lymphocytes (TIL)