Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma

Recurrent Glioblastoma Clinical Trial

Official title:

A Phase I Trial of Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05341947
• Other study ID #: IIT2019-23-Rudnick-ATC
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2022
• Est. completion date: June 2025

Study information

• Verified date: April 2022
• Source: Cedars-Sinai Medical Center
• Contact: Kortnee Calkins
• Phone: 310-285-7210
• Email: Kortnee.Calkins[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 2025
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Recurrent Glioblastoma

Intervention

Biological:
• Activated T cells
Activated T cells (ATC) administered intravenously at one timepoint

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jeremy Rudnick, M.D	Kairos Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From start of study treatment until End of Study, an average of 2 months
Secondary	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.
Secondary	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.
Secondary	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	From baseline visit to End of Study, an average of 2 months
Secondary	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	From pre-study Brain MRI through study completion or withdrawal of consent, whichever came first. Assessed up to 3 years.
Secondary	Immune Response	Assessed by cytotoxic T cell activity in vitro pre- vs post-infusion.	At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2
Secondary	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, IL13Ra2, AIM-2).	At Baseline visit and at time of recurrence. Assessed up to 3 years.