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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05333588
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hebei Senlang Biotechnology Inc., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Chunyan Li, academician
Principal Investigator Affiliation Member of the Chinese Academy of Engineering
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme, Adult
Arms & Interventions

Arms

Experimental: Tumor infiltrating lymphocyte

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

Interventions

Biological: - Tumor Infiltrating Lymphocytes (TIL)

The autologous TILs will be intravenous infused into patients.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Shijiazhuang, Hebei, China

Status

Recruiting

Address

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, 050000

Site Contact

Na Kuang

Kuangna@senlangbio.com

+8618630160116

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