Recurrent GlioblastomaPhase 1NCT07209241
Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM
A Phase 1 study testing CART-EGFR-IL13Ra2 T cells in people with Recurrent Glioblastoma, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is an open-label, phase 1b study to evaluate different approaches for CART-EGFR-IL13Ra2 dosing and further characterize the safety, feasibility, preliminary efficacy, and pharmacokinetics of CART-EGFR-IL13Ra2 cells in patients with EGFR-amplified glioblastoma that has recurred following prior radiotherapy. 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?
- CART-EGFR-IL13Ra2 T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to 1 Nov 2042
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Signed, written informed consent
- Male or female age ≥ 18 years
- Patients with glioblastoma, IDH-wildtype (as defined by WHO 2021 Classification of CNS Tumors) that has recurred following prior radiotherapy1. For patients with tumors harboring methylation of the MGMT promoter, a t l east 1 2 w eeks must have elapsed since completion of first-line radiotherapy.
- Tumor tissue positive for wild-type EGFR amplification by NeoGenomics Laboratories. Archival tumor from patient's initial surgery at time of original diagnosis or recently collected tumor from time of recurrence are acceptable.
- Surgical tumor resection for disease control/management (Arms A, B, C) or tumor biopsy to confirm tumor recurrence (Arms A and B only) is clinically indicated in the opinion of the physician-investigator.
- Adequate organ function defined as:
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- Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 30 ml/min and not on dialysis.
- ALT/AST ≤ 3 x ULN
- Total bilirubin ≤ 2.0 mg/dL, except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome (≤ 3.0 mg/dL)
- Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA
- Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
- Karnofsky Performance Status ≥ 60%.
- Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3.
Who cannot join
- Active hepatitis B or hepatitis C infection.
- Any other active, uncontrolled infection.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification
- Tumors primarily localized to the brain stem or spinal cord.
- Severe, active co-morbidity in the opinion of the physician-investigator that would preclude participation in this study.
- Receipt of bevacizumab within 3 months prior to physician-investigator confirmation of eligibility.
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- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg daily of prednisone. Patients with autoimmune neurological diseases (such as MS or Parkinson's) will be excluded.
- Patients who are pregnant or nursing (lactating).
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase Ib, Open-Label Study of CART-EGFR-IL13Rα2 Cells Administered Following Lymphodepleting Chemotherapy or Prior to Surgical Resection in Patients With EGFR-Amplified Recurrent Glioblastoma
This is an open-label, phase 1b study to evaluate different approaches for CART-EGFR-IL13Ra2 dosing and further characterize the safety, feasibility, preliminary efficacy, and pharmacokinetics of CART-EGFR-IL13Ra2 cells in patients with EGFR-amplified glioblastoma that has recurred following prior radiotherapy.
- Conditions
- Recurrent Glioblastoma
- Being tested
- CART-EGFR-IL13Ra2 T cells
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-EGFR-IL13Ra2 T cellsBiological
CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Subjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion. Receives: Biological: CART-EGFR-IL13Ra2 T cells |
| Arm B | Active comparator | Subjects will receive repeated dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion. Receives: Biological: CART-EGFR-IL13Ra2 T cells |
| Arm C | Active comparator | Subjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 in the pre-operative setting. Receives: Biological: CART-EGFR-IL13Ra2 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Type, frequency, severity, and attribution of adverse events
Measured: Up to 15 years following CART-EGFR-IL13Ra2 administration
Occurrence of treatment-limiting toxicities (Arms A and B only)
Type, frequency, severity, and attribution of treatment limiting adverse events as defined in protocol section 8.1.7
Measured: Up to 28 days following CART-EGFR-IL13Ra2 administration
Secondary outcomes (5)
Evaluate the feasibility of different approaches for CART-EGFR-IL13Ra2 dosing
Proportion of eligible subjects who receive study treatment.
Proportion of eligible subjects assigned to arm B who receive all planned doses of CART-EGFR-IL13Ra2 cells
Measured: Up to 2 years
Progression-free Survival (PFS)
Per RANO 2.0 criteria
Measured: Up to 15 years following CART-EGFR-IL13Ra2 administration
Overall Survival (OS)
Per RANO 2.0 criteria
Measured: Up to 15 years following CART-EGFR-IL13Ra2 administration
Objective Response Rate (ORR)
Per RANO 2.0 criteria in participants with measurable disease at the time of study treatment (Treatment Arms A and B) or Post-Surgical Resection (Treatment Arm C)
Measured: Up to 15 years following CART-EGFR-IL13Ra2 administration
Duration of response (DOR)
Per RANO 2.0 criteria in participants with measurable disease at the time of study treatment (Treatment Arms A and B) or Post-Surgical Resection (Treatment Arm C)
Measured: Up to 15 years following CART-EGFR-IL13Ra2 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start3 Dec 2025
- Primary completion1 Nov 2042 (estimated)
- Study completion1 Nov 2042 (estimated)
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study will evaluate three different approaches for administering CART-EGFR-IL13Ra2 cells in the setting of recurrent glioblastoma. Each dosing approach will be evaluated as a separate treatment arm as outlined below: * Arm A: Single Fixed-Dose Administration Following Lymphodepletion * Arm B: Repeat Dose Administration Following Lymphodepletion * Arm C: Single Fixed-Dose Administration in the Pre-Operative Setting Subjects will be assigned to each treatment arm sequentially according to their planned treatment date, starting with Arm C. Once Arm C is fully enrolled, enrollment into Arm A may commence. Once Arm A is fully enrolled and all required safety evaluations have been completed, an interim review of the Arm A data will be performed and evaluated in combination with cumulative CART-EGFR-IL13Ra2 experience from other studies. The results of this interim data review will be evaluated by the Clinical PI and Sponsor Medical Director and used to determine whether Treatment Arm
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Bagley, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209241
- Sponsor's protocol ID
- 10325
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2025
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib, Open-Label Study of CART-EGFR-IL13Rα2 Cells Administered Following Lymphodepleting Chemotherapy or Prior to Surgical Resection in Patients With EGFR-Amplified Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07209241
- Acronym / sponsor ID
- 10325
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 1 Nov 2042 (estimated)
- Study completion
- 1 Nov 2042 (estimated)
- First posted
- 6 Oct 2025 (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.
This is an open-label, phase 1b study to evaluate different approaches for CART-EGFR-IL13Ra2 dosing and further characterize the safety, feasibility, preliminary efficacy, and pharmacokinetics of CART-EGFR-IL13Ra2 cells in patients with EGFR-amplified glioblastoma that has recurred following prior radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study will evaluate three different approaches for administering CART-EGFR-IL13Ra2 cells in the setting of recurrent glioblastoma. Each dosing approach will be evaluated as a separate treatment arm as outlined below: * Arm A: Single Fixed-Dose Administration Following Lymphodepletion * Arm B: Repeat Dose Administration Following Lymphodepletion * Arm C: Single Fixed-Dose Administration in the Pre-Operative Setting Subjects will be assigned to each treatment arm sequentially according to their planned treatment date, starting with Arm C. Once Arm C is fully enrolled, enrollment into Arm A may commence. Once Arm A is fully enrolled and all required safety evaluations have been completed, an interim review of the Arm A data will be performed and evaluated in combination with cumulative CART-EGFR-IL13Ra2 experience from other studies. The results of this interim data review will be evaluated by the Clinical PI and Sponsor Medical Director and used to determine whether Treatment Arm
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Biological: CART-EGFR-IL13Ra2 T cellsSubjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion. |
| Arm B | Active comparator | Biological: CART-EGFR-IL13Ra2 T cellsSubjects will receive repeated dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion. |
| Arm C | Active comparator | Biological: CART-EGFR-IL13Ra2 T cellsSubjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 in the pre-operative setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed, written informed consent
- Male or female age ≥ 18 years
- Patients with glioblastoma, IDH-wildtype (as defined by WHO 2021 Classification of CNS Tumors) that has recurred following prior radiotherapy1. For patients with tumors harboring methylation of the MGMT promoter, a t l east 1 2 w eeks must have elapsed since completion of first-line radiotherapy.
- Tumor tissue positive for wild-type EGFR amplification by NeoGenomics Laboratories. Archival tumor from patient's initial surgery at time of original diagnosis or recently collected tumor from time of recurrence are acceptable.
- Surgical tumor resection for disease control/management (Arms A, B, C) or tumor biopsy to confirm tumor recurrence (Arms A and B only) is clinically indicated in the opinion of the physician-investigator.
Key exclusion criteria (9 listed)
- Active hepatitis B or hepatitis C infection.
- Any other active, uncontrolled infection.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification
- Tumors primarily localized to the brain stem or spinal cord.
- Severe, active co-morbidity in the opinion of the physician-investigator that would preclude participation in this study.
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 |
|---|---|---|
| CART-EGFR-IL13Ra2 T cellsCART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2. | Biological | Arm A, Arm B, Arm C |
Primary outcome
Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Type, frequency, severity, and attribution of adverse events
Occurrence of treatment-limiting toxicities (Arms A and B only)
Time frame: Up to 28 days following CART-EGFR-IL13Ra2 administration
Type, frequency, severity, and attribution of treatment limiting adverse events as defined in protocol section 8.1.7
5 secondary outcomes
Evaluate the feasibility of different approaches for CART-EGFR-IL13Ra2 dosing
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Overall Survival (OS)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Objective Response Rate (ORR)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Duration of response (DOR)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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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.
Stephen Bagley, MD, MSCE principal investigator
University of Pennsylvania
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 CART-EGFR-IL13Ra2 T cells in people with Recurrent Glioblastoma, run by University of Pennsylvania 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 13 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0 (time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration). The study lists 2 primary outcomes in all. 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 21 Aug 2026.