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Adoptive Cell Therapy of Autologous TIL and PD1-TIL Cells for Patients With Glioblastoma Multiforme

Primary Purpose

Glioblastoma Multiforme

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

TIL

PD1-TIL

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring glioma, TIL, PD1-TIL, immunotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Recurrent patients with histologically confirmed brain glioblastoma multiforme.
Patients with maximum safe resection of the tumor (≥95%) confirmed with contrast MR or CT within 72 hours after surgery.
Age from 18 to 70 years.
Karnofsky performance score ≥ 60.
Adequate organ function within 14 days of study registration including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count, (ANC) ≥ 1.0×10^9/L, platelets ≥100×10^9/L; hemoglobin ≥ 9 g/dL. Hepatic: bilirubin ≤1.3 mg/dL or 0-22 mmol/L, aspartate transaminase (AST) and alanine transaminase (ALT) < 3×upper limit of normal (ULN). Renal: Normal serum Creatinine for age (below) or creatinine clearance >60 ml/min/1.73 m2. Electrocardiogram: normal.
Written informed consent must be obtained from all patients.

Exclusion Criteria:

Pregnant or breast-feeding patients. Pregnancy testing will be performed on all menstruating females within 14 days of study enrollment.
Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with history of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication of cortisol.
Patients with any conditions that could potentially alter immune function (e.g., AIDS, multiple sclerosis, diabetes, renal failure).

Patients currently received any other investigational agents.

Sites / Locations

Huashan hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

TIL cells

PD1-TIL cells

Arm Description

10 days after the end of chemotherapy or radiotherapy，the 300ml TIL cells ( TIL saline + 0.25% human serum albumin) was injected intravenously 2 times every 30 days .

10 days after the end of chemotherapy or radiotherapy，the 300ml PD1-TIL cells ( PD1-TIL saline + 0.25% human serum albumin) was injected intravenously 2 times every 30 days .

Outcomes

Primary Outcome Measures

Number of Adverse Events related to TIL and PD1-TIL cells infusion

Secondary Outcome Measures

Treatment Responses Rate

Overall Survival Rate

Progression-free Survival Rate

Full Information

NCT ID

NCT03347097

First Posted

November 2, 2017

Last Updated

August 24, 2021

Sponsor

Huashan Hospital

Collaborators

Shanghai Cell Therapy Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT03347097

Brief Title

Adoptive Cell Therapy of Autologous TIL and PD1-TIL Cells for Patients With Glioblastoma Multiforme

Official Title

The Safety and Efficacy Study of Autologous Tumor-infiltrating T Lymphocyte（TIL）and Transgenic Modified TIL Cells Adoptive Therapies for Patients With Glioblastoma Multiforme

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

Collaborators

Shanghai Cell Therapy Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

At present, the investigators want to evaluate safety and efficacy of cell therapy based on Tumor-infiltrating T Lymphocyte (TIL）in glioblastoma. Here, we also constructed a transgenic modified TIL cells, stablely express a high-level full-length PD1 antibody (PD1-TIL cells), which can transduce signals to activate T cells and result in tumor killing. In this study, we design two group patients treated with TIL cells and PD1-TIL cells respectively to determine the safety and efficacy of autologous TILs or genetically modified TILs in patients with glioblastoma.

6. Conditions and Keywords

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

Glioblastoma Multiforme

Keywords

glioma, TIL, PD1-TIL, immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TIL cells

Arm Type

Experimental

Arm Description

10 days after the end of chemotherapy or radiotherapy，the 300ml TIL cells ( TIL saline + 0.25% human serum albumin) was injected intravenously 2 times every 30 days .

Arm Title

PD1-TIL cells

Arm Type

Experimental

Arm Description

10 days after the end of chemotherapy or radiotherapy，the 300ml PD1-TIL cells ( PD1-TIL saline + 0.25% human serum albumin) was injected intravenously 2 times every 30 days .

Intervention Type

Drug

Intervention Name(s)

TIL

Intervention Type

Drug

Intervention Name(s)

PD1-TIL

Primary Outcome Measure Information:

Title

Number of Adverse Events related to TIL and PD1-TIL cells infusion

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Treatment Responses Rate

Time Frame

6 months

Title

Overall Survival Rate

Time Frame

24 months

Title

Progression-free Survival Rate

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Recurrent patients with histologically confirmed brain glioblastoma multiforme. Patients with maximum safe resection of the tumor (≥95%) confirmed with contrast MR or CT within 72 hours after surgery. Age from 18 to 70 years. Karnofsky performance score ≥ 60. Adequate organ function within 14 days of study registration including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count, (ANC) ≥ 1.0×10^9/L, platelets ≥100×10^9/L; hemoglobin ≥ 9 g/dL. Hepatic: bilirubin ≤1.3 mg/dL or 0-22 mmol/L, aspartate transaminase (AST) and alanine transaminase (ALT) < 3×upper limit of normal (ULN). Renal: Normal serum Creatinine for age (below) or creatinine clearance >60 ml/min/1.73 m2. Electrocardiogram: normal. Written informed consent must be obtained from all patients. Exclusion Criteria: Pregnant or breast-feeding patients. Pregnancy testing will be performed on all menstruating females within 14 days of study enrollment. Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. Patients with history of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication of cortisol. Patients with any conditions that could potentially alter immune function (e.g., AIDS, multiple sclerosis, diabetes, renal failure). Patients currently received any other investigational agents. -

Facility Information:

Facility Name

Huashan hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Adoptive Cell Therapy of Autologous TIL and PD1-TIL Cells for Patients With Glioblastoma Multiforme

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