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

Primary Purpose

Recurrent Glioblastoma

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Activated T cells
Sponsored by
Jeremy Rudnick, M.D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring glioma, brain tumor, glioblastoma, neurosurgery, surgical resection, Complete resection of tumor, extent of resection, maximal safe resection, neuropathology, astrocytoma, ependymoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Activated T cells

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival (OS)
Progression-Free Survival (PFS)
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
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
Immune Response
Assessed by cytotoxic T cell activity in vitro pre- vs post-infusion.
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).

Full Information

First Posted
March 24, 2022
Last Updated
April 21, 2022
Sponsor
Jeremy Rudnick, M.D
Collaborators
Kairos Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05341947
Brief Title
Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma
Official Title
A Phase I Trial of Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeremy Rudnick, M.D
Collaborators
Kairos Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
Keywords
glioma, brain tumor, glioblastoma, neurosurgery, surgical resection, Complete resection of tumor, extent of resection, maximal safe resection, neuropathology, astrocytoma, ependymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Activated T cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Activated T cells
Intervention Description
Activated T cells (ATC) administered intravenously at one timepoint
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
Health-related quality of life parameters
Description
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
Title
Overall Response Rate (ORR)
Description
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.
Title
Immune Response
Description
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
Title
Tumor stem cell antigen expression
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kortnee Calkins
Phone
310-285-7210
Email
Kortnee.Calkins@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Rudnick, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kortnee Calkins
Phone
310-285-7210
Email
Kortnee.Calkins@cshs.org
First Name & Middle Initial & Last Name & Degree
Jethro Hu, MD
First Name & Middle Initial & Last Name & Degree
Justin Darrah, MD
First Name & Middle Initial & Last Name & Degree
Ray Chu, MD
First Name & Middle Initial & Last Name & Degree
Chirag Patil, MD

12. IPD Sharing Statement

Learn more about this trial

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

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