Status:
UNKNOWN
Adoptive Cell Therapy of Autologous TIL and PD1-TIL Cells for Patients With Glioblastoma Multiforme
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Shanghai Cell Therapy Research Institute
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
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 ce...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03347097
Start Date
January 1 2017
End Date
December 1 2021
Last Update
August 25 2021
Active Locations (1)
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1
Huashan hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040