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

NCT ID: NCT05333588

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2025-02-15

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.

Conditions

Glioblastoma Multiforme, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tumor infiltrating lymphocyte

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

Group Type: EXPERIMENTAL

Tumor Infiltrating Lymphocytes (TIL)

Intervention Type: BIOLOGICAL

The autologous TILs will be intravenous infused into patients.

Interventions

Tumor Infiltrating Lymphocytes (TIL)

The autologous TILs will be intravenous infused into patients.

Intervention Type: BIOLOGICAL

Other Intervention Names

TILs

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunyan Li, academician

Role: PRINCIPAL_INVESTIGATOR

Member of the Chinese Academy of Engineering

Locations

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Na Kuang

Role: CONTACT

kuangna@senlangbio.com

+8618630160116

Facility Contacts

Na Kuang

Role: primary

Kuangna@senlangbio.com

+8618630160116

Other Identifiers

TILs for Glioblastoma

Identifier Type: -

Identifier Source: org_study_id