Recurrent Glioblastoma
Conditions
Keywords
glioma, brain tumor, glioblastoma, neurosurgery, surgical resection, Complete resection of tumor, extent of resection, maximal safe resection, neuropathology, astrocytoma, ependymoma
Brief summary
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.
Interventions
BIOLOGICALActivated T cells
Activated T cells (ATC) administered intravenously at one timepoint
Sponsors
Kairos Pharma
Jeremy Rudnick, M.D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recurrent glioblastoma * HLA-A1 and HLA-A2 positive * Complete resection of tumor
Exclusion criteria
* Clinically significant pulmonary, cardiac or other systemic disease * Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed. * Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition. * Known history of Hepatitis B or Hepatitis C * Allergy to Dimethyl sulfoxide (DMSO) * Allergy to gentamicin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From start of study treatment until End of Study, an average of 2 months | Recorded and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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 | From baseline visit to End of Study, an average of 2 months | 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 |
| Overall Survival (OS) | From date of enrollment to date of death of any cause or withdrawal of consent, whichever came first. Assessed up to 3 years. | — |
| Immune Response | At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2 | Assessed by cytotoxic T cell activity in vitro pre- vs post-infusion. |
| Tumor stem cell antigen expression | At Baseline visit and at time of recurrence. Assessed up to 3 years. | Assessed by quantitative PCR for expression of CD133, housekeeping genes, and tumor associated antigens (including HER2, TRP-2, gp100, MAGE-1, IL13Rα2, AIM-2). |
| Overall Response Rate (ORR) | From pre-study Brain MRI through study completion or withdrawal of consent, whichever came first. Assessed up to 3 years. | 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 |
Countries
United States
Outcome results
None listed