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

The Safety and Efficacy Study of Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy Combined With Conventional Chemotherapy for Patients With Advanced Stage of Glioblastoma Multiforme.

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma Multiforme, Adult
• Intervention / Treatment: Biological: Tumor Infiltrating Lymphocytes (TIL)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Na Kuang; Phone Number: +8618630160116; Email: Kuangna@senlangbio.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Na Kuang; Phone Number: +8618630160116; Email: Kuangna@senlangbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tumor infiltrating lymphocyte; 1x10^9-5x10^10 of autologous TILs will be adoptive transfer to patients.	Biological: Tumor Infiltrating Lymphocytes (TIL); The autologous TILs will be intravenous infused into patients.; Other Names: TILs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)		24 months
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

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Investigators: Principal Investigator: Chunyan Li, academician, Member of the Chinese Academy of Engineering

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2022
• Primary Completion (ANTICIPATED): February 15, 2024
• Study Completion (ANTICIPATED): February 15, 2025

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (ACTUAL): April 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Glioblastoma Multiforme; glioma; TiLs
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: TILs for Glioblastoma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No