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

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03347097
• Other study ID #: KY2017-241
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2021
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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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Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• TIL

• PD1-TIL

Locations

Country	Name	City	State
China	Huashan hospital, Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Shanghai Cell Therapy Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events related to TIL and PD1-TIL cells infusion		1 month
Secondary	Treatment Responses Rate		6 months
Secondary	Overall Survival Rate		24 months
Secondary	Progression-free Survival Rate		12 months