The purpose of this study is to examine the use of activated T cells (ATCs) to assess the safety and tolerability of autologous activated T cells, as measured by the number of Grade 3 or higher toxicities, the number of serious adverse events, and treatment-related toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of overall survival, rate of progression-free survival, health-related quality of life parameters, overall response rate, immune response, and tumor stem cell antigen expression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Activated T cells (ATC) administered intravenously at one timepoint
Cedars-Sinai Medical Center
Los Angeles, California, United States
Number of Grade 3 or higher toxicities, number of serious adverse events, and the number of treatment-related toxicities to find the maximum tolerated dose
Recorded and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5
Time frame: From start of study treatment until End of Study, an average of 2 months
Overall Survival (OS)
Time frame: From date of enrollment to date of death of any cause or withdrawal of consent, whichever came first. Assessed up to 3 years.
Progression-Free Survival (PFS)
Time frame: From start of study treatment, until confirmation of disease progression or withdrawal of consent, whichever came first. Assessed up to 3 years.
Health-related quality of life parameters
Measured by change in the Functional Assessment of Cancer Therapy - Brain (FACT-Br) survey score. The FACT-Br total score has a range of 0-200 and higher scores indicate better quality of life
Time frame: From baseline visit to End of Study, an average of 2 months
Overall Response Rate (ORR)
Percentage of patients showing either partial response or complete response, in patients with subtotal resection, will be measured using Magnetic Resonance Imaging (MRI) and Immunotherapy Response Assessment in Neuro-Oncology (iRANO) Response Criteria
Time frame: From pre-study Brain MRI through study completion or withdrawal of consent, whichever came first. Assessed up to 3 years.
Immune Response
Assessed by cytotoxic T cell activity in vitro pre- vs post-infusion.
Time frame: At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2
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Tumor stem cell antigen expression
Assessed by quantitative PCR for expression of CD133, housekeeping genes, and tumor associated antigens (including HER2, TRP-2, gp100, MAGE-1, IL13Rα2, AIM-2).
Time frame: At Baseline visit and at time of recurrence. Assessed up to 3 years.