Status:
UNKNOWN
The Safety Study of Autologous TILs Therapy for Patients With Glioblastoma Multiforme.
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Conditions:
Glioblastoma Multiforme, Adult
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
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 infus...
Eligibility Criteria
Inclusion
- Age: 18 to 80 years old;
- Has at least one measurable tumor foci;
- ECOG score range : 0-2;
- Expected survival time: ≥ 3 months;
- 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;
- 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.
- Be willing and able to provide written informed consent/assent for the trial.
Exclusion
- Has systemic active infection and requiring treatment;
- Has severe physical or mental illness;
- Has active rheumatic disease;
- Has any kinds of organ transplantation;
- Being pregnant or lactating;
- Enrolled in other clinical trials within 4 weeks prior to registration;
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C;
- Other conditions that the researcher considered to be excluded;
- 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.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05333588
Start Date
February 15 2022
End Date
February 15 2025
Last Update
April 19 2022
Active Locations (1)
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1
The Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, China, 050000