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

NCT ID: NCT03347097

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2021-12-01

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.

Conditions

Glioblastoma Multiforme

Study Design

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

Study Groups

TIL cells

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 .

Group Type: EXPERIMENTAL

TIL

Intervention Type: DRUG

PD1-TIL cells

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 .

Group Type: EXPERIMENTAL

PD1-TIL

Intervention Type: DRUG

Interventions

TIL

Intervention Type: DRUG

PD1-TIL

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Recurrent patients with histologically confirmed brain glioblastoma multiforme.

2. Patients with maximum safe resection of the tumor (≥95%) confirmed with contrast MR or CT within 72 hours after surgery.

3. Age from 18 to 70 years.

4. Karnofsky performance score ≥ 60.

5. 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.

6. Written informed consent must be obtained from all patients.

Exclusion Criteria

1. 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.

2. 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.

3. 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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Cell Therapy Research Institute

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu Yao, MD

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huashan hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

KY2017-241

Identifier Type: -

Identifier Source: org_study_id