NCT03347097UnknownEarly Phase 1
The Safety and Efficacy Study of Autologous Tumor-infiltrating T Lymphocyte（TIL）and Transgenic Modified TIL Cells Adoptive Therapies for Patients With Glioblastoma Multiforme
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- Huashan Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Adverse Events related to TIL and PD1-TIL cells infusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •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 m
- •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.
Arms & Interventions
TIL cells
Experimental
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 .
Intervention: TIL (Drug)
PD1-TIL cells
Experimental
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: PD1-TIL (Drug)
Outcomes
Primary Outcomes
Number of Adverse Events related to TIL and PD1-TIL cells infusion
Time Frame: 1 month
Secondary Outcomes
- Progression-free Survival Rate(12 months)
- Treatment Responses Rate(6 months)
- Overall Survival Rate(24 months)
Investigators
Yu Yao, MD
Resident
Huashan Hospital
Study Sites (1)
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