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

Primary Purpose

Glioblastoma Multiforme, Adult

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Tumor Infiltrating Lymphocytes (TIL)

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme, Adult focused on measuring glioma, TiLs, Glioblastoma Multiforme

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Second Hospital of HeBei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tumor infiltrating lymphocyte

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Objective response rate (ORR)

Full Information

NCT ID

NCT05333588

First Posted

April 1, 2022

Last Updated

April 11, 2022

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05333588

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 15, 2022 (Actual)

Primary Completion Date

February 15, 2024 (Anticipated)

Study Completion Date

February 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme, Adult

Keywords

glioma, TiLs, Glioblastoma Multiforme

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tumor infiltrating lymphocyte

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Tumor Infiltrating Lymphocytes (TIL)

Other Intervention Name(s)

TILs

Intervention Description

The autologous TILs will be intravenous infused into patients.

Primary Outcome Measure Information:

Title

Number of adverse events related to TiLs infusion

Description

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.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Progressional free of survival (PFS)

Description

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.

Time Frame

Up to 24 months

Title

Objective response rate (ORR)

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Na Kuang

Phone

+8618630160116

kuangna@senlangbio.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunyan Li, academician

Organizational Affiliation

Member of the Chinese Academy of Engineering

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second Hospital of HeBei Medical University

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Na Kuang

Phone

+8618630160116

Kuangna@senlangbio.com

12. IPD Sharing Statement

Learn more about this trial

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

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