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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor infiltrating lymphocyte | Experimental | 1x10^9-5x10^10 of autologous TILs will be adoptive transfer to patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Infiltrating Lymphocytes (TIL) | Biological | The autologous TILs will be intravenous infused into patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events related to TiLs infusion | The primary outcome measure of this clinical trial is accessed by the safety of the TILs product. The safety profile for TILs is characterized by its incidence of the adverse events. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Progressional free of survival (PFS) | PFS is defined as the duration of time from start of treatment to time of progression. All patients will be followed for a minimum of 2 years. | Up to 24 months |
| Objective response rate (ORR) |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na Kuang | Contact | +8618630160116 | kuangna@senlangbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunyan Li, academician | Member of the Chinese Academy of Engineering | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of HeBei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| 24 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |