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

October 20, 2025 updated by: Jeremy Rudnick, M.D

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activated T cells
Biological: Activated T cells
Activated T cells (ATC) administered intravenously at one timepoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From start of study treatment until End of Study, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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
Time Frame: 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
From baseline visit to End of Study, an average of 2 months
Overall Response Rate (ORR)
Time Frame: 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
From pre-study Brain MRI through study completion or withdrawal of consent, whichever came first. Assessed up to 3 years.
Immune Response
Time Frame: 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.
At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2
Tumor stem cell antigen expression
Time Frame: 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).
At Baseline visit and at time of recurrence. Assessed up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeremy Rudnick, M.D

Collaborators

Kairos Pharma

Investigators

  • Principal Investigator: Jeremy Rudnick, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Estimated)

October 22, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2019-23-Rudnick-ATC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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