A Phase I Trial of Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma
Overview
- Phase
- Phase 1
- Intervention
- Activated T cells
- Conditions
- Recurrent Glioblastoma
- Sponsor
- Jeremy Rudnick, M.D
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Withdrawn
- Last Updated
- 6 months ago
Overview
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.
Investigators
Jeremy Rudnick, M.D
Co-Director, Neuro-Oncology
Cedars-Sinai Medical Center
Eligibility Criteria
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
Arms & Interventions
Activated T cells
Intervention: Activated T cells
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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.)
- 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)
- Tumor stem cell antigen expression(At Baseline visit and at time of recurrence. Assessed up to 3 years.)
- Immune Response(At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 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.)