Recurrent GlioblastomaPhase 1NCT05341947
Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma
A Phase 1 study testing Activated T cells in people with Recurrent Glioblastoma, run by Jeremy Rudnick, M.D at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Activated T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent glioblastoma
- HLA-A1 and HLA-A2 positive
- Complete resection of tumor
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Activated T cells
- Keywords
- glioma, brain tumor, glioblastoma, neurosurgery, surgical resection, Complete resection of tumor, extent of resection, maximal safe resection, neuropathology, astrocytoma, ependymoma
- Medical subject headings
- Glioblastoma, Glioma, Brain Neoplasms, Astrocytoma, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated T cellsBiological
Activated T cells (ATC) administered intravenously at one timepoint
| Study group | Role | What they receive |
|---|---|---|
| Activated T cells | Experimental | Not described Receives: Biological: Activated T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From start of study treatment until End of Study, an average of 2 months
Secondary outcomes (6)
Overall Survival (OS)
Measured: 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)
Measured: 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
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
Measured: From baseline visit to End of Study, an average of 2 months
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
Measured: From pre-study Brain MRI through study completion or withdrawal of consent, whichever came first. Assessed up to 3 years.
Immune Response
Assessed by cytotoxic T cell activity in vitro pre- vs post-infusion.
Measured: At Visit 1, Post-immunotherapy infusion follow-up Day 14, and Survival follow-up Month 2
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).
Measured: At Baseline visit and at time of recurrence. Assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeremy Rudnick, M.D
- Sponsor type
- University, hospital or other
- Collaborators
- Kairos Pharma
- Responsible party
- Sponsor-investigator, Jeremy Rudnick, M.D, Cedars-Sinai Medical Center
- Investigators
- Jeremy Rudnick, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341947
- Sponsor's protocol ID
- IIT2019-23-Rudnick-ATC
- Status last verified
- Sep 2025
- First submitted
- 24 Mar 2022
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT05341947
- Acronym / sponsor ID
- IIT2019-23-Rudnick-ATC
- Conditions
- Recurrent Glioblastoma
- Keywords
- glioma, brain tumor, glioblastoma, neurosurgery, surgical resection, Complete resection of tumor, extent of resection, maximal safe resection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jeremy Rudnick, M.DUniversity, hospital or other
- Collaborators
- Kairos Pharma
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activated T cells | Experimental | Biological: Activated T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent glioblastoma
- HLA-A1 and HLA-A2 positive
- Complete resection of tumor
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated T cellsActivated T cells (ATC) administered intravenously at one timepoint | Biological | Activated T cells |
Primary outcome
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
6 secondary outcomes
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.
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.
Health-related quality of life parameters
Time frame: 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.
Immune Response
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Rudnick, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Activated T cells in people with Recurrent Glioblastoma, run by Jeremy Rudnick, M.D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.