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

  • STATUS
    Recruiting
  • End date
    Feb 15, 2025
  • participants needed
    20
  • sponsor
    Hebei Senlang Biotechnology Inc., Ltd.
Updated on 30 April 2022

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.

Details
Condition Glioblastoma Multiforme, Adult
Treatment Tumor Infiltrating Lymphocytes (TIL)
Clinical Study IdentifierNCT05333588
SponsorHebei Senlang Biotechnology Inc., Ltd.
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses

How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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