Clinical trial NCT05333588: The Safety Study of Autologous TILs Therapy for Patients With Glioblastoma Multiforme.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Glioblastoma Multiforme, Adult
Keywords: glioma
TiLs
Glioblastoma Multiforme
Lead sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events related to TiLs infusion
timeFrame: 1 month
Secondary outcomes:
measure: Progressional free of survival (PFS)
timeFrame: Up to 24 months
measure: Objective response rate (ORR)
timeFrame: 24 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of HeBei Medical University
state: Hebei
Study officials:
affiliation: Member of the Chinese Academy of Engineering
name: Chunyan Li, academician
role: PRINCIPAL_INVESTIGATOR
References: