GlioblastomaPhase 1NCT05168423
CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM
A Phase 1 study testing CART-EGFR-IL13Ra2 Cells in people with Glioblastoma, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype 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
- Glioblastoma
- What is being tested?
- CART-EGFR-IL13Ra2 Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to 19 Dec 2039
- 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 radiotherapy. For patients with tumors harboring methylation of the MGMT promoter, at least 12 weeks 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 or tumor biopsy to confirm tumor recurrence 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 upper limit of normal range and 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.
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 1, Open-label Study Evaluating the Safety and Feasibility of CART-EGFR-IL13Ra2 Cells in Patients With EGFR-Amplified Recurrent Glioblastoma
This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype that has recurred following prior radiotherapy.
- Conditions
- Glioblastoma
- Being tested
- CART-EGFR-IL13Ra2 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 CellsDrug
autologous T cells transduced with a bicistronic lentiviral vector containing a murine scFv targeting EGFR and a humanized scFv targeting IL13Ra2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive a single fixed dose of 1x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0. Receives: Drug: CART-EGFR-IL13Ra2 Cells |
| Cohort -1 | Experimental | Participants will receive a single fixed dose of 5x10^6 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0. Receives: Drug: CART-EGFR-IL13Ra2 Cells |
| Cohort 2 | Experimental | Participants will receive a single fixed dose of 2.5x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0. Receives: Drug: CART-EGFR-IL13Ra2 Cells |
| Cohort 3 | Experimental | Participants will receive a single fixed dose of 5x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0. Receives: Drug: CART-EGFR-IL13Ra2 Cells |
| Cohort 4 | Experimental | Participants will receive a single dose of 2.5x107 CART-EGFR-IL13Ra2 cells given via intrathecal administration on Day 0, followed by a second dose of 2.5x107 CART-EGFR-IL13Ra2 cells given via intrathecal administration on Day 14 (+/-1d). Receives: Drug: CART-EGFR-IL13Ra2 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
Number of subjects with dose-limiting toxicities (DLTs)
Dose Escalation Phase only; Unacceptable toxicity as defined by the protocol
Measured: 28 days following initial treatment with CART-EGFR-IL13Ra2 cells
Determination of maximum tolerated dose (MTD).
Dose Escalation Phase only: The maximum tolerated dose (MTD) is defined as the highest dose explored at which 0 or 1 DLT occurs in 6 evaluable subjects.
Measured: 28 days following initial treatment with CART-EGFR-IL13Ra2 cellsnths
Determine the recommended dose for expansion (RDE).
Measured: Up to 12 months following initial treatment with CART-EGFR-IL13Ra2 cells
Proportion of eligible subjects who receive all planned doses of CART-EGFR-IL13Ra2 cells.
Cohort 4 only
Measured: 28 days following initial treatment with CART-EGFR-IL13Ra2 cells
Secondary outcomes (6)
Proportion of subjects who enroll on this study who received study treatment.
Evaluated based on the proportion of subjects who screen fail and those who receive any dose of CART-EGFR-IL13Ra2 cells.
Measured: 12 months
Frequency of manufacturing failures
Proportion of subjects with CART-EGFR-IL13Ra2 products that fail to meet the product release criteria, out of the number of subjects in whom manufacturing was attempted.
Proportion of subjects with CART-EGFR-IL13Ra2 products that fail to meet the assigned dose, out of the number of subjects in whom manufacturing was attempted.
Measured: 3 months
Progression-Free Survival (PFS)
Per modified RANO criteria
Measured: Up to 15 years following CART-EGFR-IL13Ra2 administration
Objective Response Rate (ORR)
Per modified RANO criteria (in subjects with measurable disease at the time of study treatment); Proportion of subjects with confirmed CR and PR.
Measured: Up to 12 months following CART-EGFR-IL13Ra2 administration
Duration of response (DOR)
Per modified RANO criteria (in subjects with measurable disease at the time of study treatment); Time from the date when a response of confirmed CR/PR is first met to the date of confirmed disease progression, death or receipt of alternative treatment other than CART-EGFR-IL13Ra2 retreatment.
Measured: Up to 15 years following initial CART-EGFR-IL13Ra2 administration
Overall Survival (OS)
Time from initial study treatment to the date of death from any cause.
Measured: Up to 15 years following initial 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 posted23 Dec 2021
- Study start24 Feb 2023
- Primary completion19 Dec 2039 (estimated)
- Study completion19 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- 3+3 Dose escalation design
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Kite Pharma (a Gilead Company)
- Responsible party
- Sponsor
- Investigators
- Stephen Bagley, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168423
- Sponsor's protocol ID
- 16321
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Freeburg NF, Chafamo D, Konanur Gopikrishna G, Murphy RM, Peng JJ, Parthasarathy S, Dumont S, Estrada EG, Logun MT, Sun Y, Wang X, Grover P, Rodriguez JL, Zhang DL, Park K, Fu Y, Ben Hamouda N, Hernandez-Verdin I, Lamrani L, Hicks KA, Cooper NA, Ekwegbara C, Bawden EG, Waterfall JJ, Fuentealba J, Alcantara M, Seykora JT, Prouty SM, Barrett D, Banerjee E, Cox A, Assenmacher CA, Macia C, Yin M, Carpenter EL, Ming GL, Sautes-Fridman C, Fridman WH, Tartour E, Wherry EJ, Amigorena S, Fraietta JA, Nasrallah MP, Song H, Miller TE, Bagley SJ, O'Rourke DM, Binder ZA, Alanio C, Silverbush D. The critical role of the endogenous immune compartment after CAR T cell therapy in recurrent GBM. Cell. 2026 Jun 15:S0092-8674(26)00585-4. doi: 10.1016/j.cell.2026.05.026. Online ahead of print.
PubMed 42296961Bagley SJ, Desai AS, Fraietta JA, Silverbush D, Chafamo D, Freeburg NF, Gopikrishna GK, Rech AJ, Nabavizadeh A, Bagley LJ, Park J, Jarocha D, Martins R, Sarmiento N, Maloney E, Lledo L, Stein C, Marshall A, Leskowitz RM, Jadlowsky JK, Mackey S, Christensen S, Oner BS, Plesa G, Brennan A, Gonzalez V, Chen F, Barrett D, Colbourn R, Nasrallah MP, Mourelatos Z, Hwang WT, Alanio C, Siegel DL, June CH, Hexner EO, Binder ZA, O'Rourke DM. Intracerebroventricular bivalent CAR T cells targeting EGFR and IL-13Ralpha2 in recurrent glioblastoma: a phase 1 trial. Nat Med. 2025 Aug;31(8):2778-2787. doi: 10.1038/s41591-025-03745-0. Epub 2025 Jun 1.
PubMed 40451950Bagley SJ, Logun M, Fraietta JA, Wang X, Desai AS, Bagley LJ, Nabavizadeh A, Jarocha D, Martins R, Maloney E, Lledo L, Stein C, Marshall A, Leskowitz R, Jadlowsky JK, Christensen S, Oner BS, Plesa G, Brennan A, Gonzalez V, Chen F, Sun Y, Gladney W, Barrett D, Nasrallah MP, Hwang WT, Ming GL, Song H, Siegel DL, June CH, Hexner EO, Binder ZA, O'Rourke DM. Intrathecal bivalent CAR T cells targeting EGFR and IL13Ralpha2 in recurrent glioblastoma: phase 1 trial interim results. Nat Med. 2024 May;30(5):1320-1329. doi: 10.1038/s41591-024-02893-z. Epub 2024 Mar 13.
PubMed 38480922
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label Study Evaluating the Safety and Feasibility of CART-EGFR-IL13Ra2 Cells in Patients With EGFR-Amplified Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT05168423
- Acronym / sponsor ID
- 16321
- Conditions
- Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Kite Pharma (a Gilead Company)
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 19 Dec 2039 (estimated)
- Study completion
- 19 Dec 2039 (estimated)
- First posted
- 23 Dec 2021 (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 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype that has recurred following prior radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 3+3 Dose escalation design
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CART-EGFR-IL13Ra2 CellsParticipants will receive a single fixed dose of 1x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0. |
| Cohort -1 | Experimental | Drug: CART-EGFR-IL13Ra2 CellsParticipants will receive a single fixed dose of 5x10^6 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0. |
| Cohort 2 | Experimental | Drug: CART-EGFR-IL13Ra2 CellsParticipants will receive a single fixed dose of 2.5x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0. |
| Cohort 3 | Experimental | Drug: CART-EGFR-IL13Ra2 CellsParticipants will receive a single fixed dose of 5x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0. |
| Cohort 4 | Experimental | Drug: CART-EGFR-IL13Ra2 CellsParticipants will receive a single dose of 2.5x107 CART-EGFR-IL13Ra2 cells given via intrathecal administration on Day 0, followed by a second dose of 2.5x107 CART-EGFR-IL13Ra2 cells given via intrathecal administration on Day 14 (+/-1d). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 radiotherapy. For patients with tumors harboring methylation of the MGMT promoter, at least 12 weeks 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 or tumor biopsy to confirm tumor recurrence 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 Cellsautologous T cells transduced with a bicistronic lentiviral vector containing a murine scFv targeting EGFR and a humanized scFv targeting IL13Ra2 | Drug | Cohort -1, Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
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
Number of subjects with dose-limiting toxicities (DLTs)
Time frame: 28 days following initial treatment with CART-EGFR-IL13Ra2 cells
Dose Escalation Phase only; Unacceptable toxicity as defined by the protocol
Determination of maximum tolerated dose (MTD).
Time frame: 28 days following initial treatment with CART-EGFR-IL13Ra2 cellsnths
Dose Escalation Phase only: The maximum tolerated dose (MTD) is defined as the highest dose explored at which 0 or 1 DLT occurs in 6 evaluable subjects.
Determine the recommended dose for expansion (RDE).
Time frame: Up to 12 months following initial treatment with CART-EGFR-IL13Ra2 cells
Proportion of eligible subjects who receive all planned doses of CART-EGFR-IL13Ra2 cells.
Time frame: 28 days following initial treatment with CART-EGFR-IL13Ra2 cells
Cohort 4 only
6 secondary outcomes
Proportion of subjects who enroll on this study who received study treatment.
Time frame: 12 months
Frequency of manufacturing failures
Time frame: 3 months
Progression-Free Survival (PFS)
Time frame: Up to 15 years following CART-EGFR-IL13Ra2 administration
Objective Response Rate (ORR)
Time frame: Up to 12 months following CART-EGFR-IL13Ra2 administration
Duration of response (DOR)
Time frame: Up to 15 years following initial CART-EGFR-IL13Ra2 administration
Overall Survival (OS)
Time frame: Up to 15 years following initial 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 13 Apr 2026.
- Derived from this study: PubMed 42296961Freeburg NF, Chafamo D, Konanur Gopikrishna G, Murphy RM, Peng JJ, Parthasarathy S, Dumont S, Estrada EG, Logun MT, Sun Y, Wang X, Grover P, Rodriguez JL, Zhang DL, Park K, Fu Y, Ben Hamouda N, Hernandez-Verdin I, Lamrani L, Hicks KA, Cooper NA, Ekwegbara C, Bawden EG, Waterfall JJ, Fuentealba J, Alcantara M, Seykora JT, Prouty SM, Barrett D, Banerjee E, Cox A, Assenmacher CA, Macia C, Yin M, Carpenter EL, Ming GL, Sautes-Fridman C, Fridman WH, Tartour E, Wherry EJ, Amigorena S, Fraietta JA, Nasrallah MP, Song H, Miller TE, Bagley SJ, O'Rourke DM, Binder ZA, Alanio C, Silverbush D. The critical role of the endogenous immune compartment after CAR T cell therapy in recurrent GBM. Cell. 2026 Jun 15:S0092-8674(26)00585-4. doi: 10.1016/j.cell.2026.05.026. Online ahead of print.
- Derived from this study: PubMed 40451950Bagley SJ, Desai AS, Fraietta JA, Silverbush D, Chafamo D, Freeburg NF, Gopikrishna GK, Rech AJ, Nabavizadeh A, Bagley LJ, Park J, Jarocha D, Martins R, Sarmiento N, Maloney E, Lledo L, Stein C, Marshall A, Leskowitz RM, Jadlowsky JK, Mackey S, Christensen S, Oner BS, Plesa G, Brennan A, Gonzalez V, Chen F, Barrett D, Colbourn R, Nasrallah MP, Mourelatos Z, Hwang WT, Alanio C, Siegel DL, June CH, Hexner EO, Binder ZA, O'Rourke DM. Intracerebroventricular bivalent CAR T cells targeting EGFR and IL-13Ralpha2 in recurrent glioblastoma: a phase 1 trial. Nat Med. 2025 Aug;31(8):2778-2787. doi: 10.1038/s41591-025-03745-0. Epub 2025 Jun 1.
- Derived from this study: PubMed 38480922Bagley SJ, Logun M, Fraietta JA, Wang X, Desai AS, Bagley LJ, Nabavizadeh A, Jarocha D, Martins R, Maloney E, Lledo L, Stein C, Marshall A, Leskowitz R, Jadlowsky JK, Christensen S, Oner BS, Plesa G, Brennan A, Gonzalez V, Chen F, Sun Y, Gladney W, Barrett D, Nasrallah MP, Hwang WT, Ming GL, Song H, Siegel DL, June CH, Hexner EO, Binder ZA, O'Rourke DM. Intrathecal bivalent CAR T cells targeting EGFR and IL13Ralpha2 in recurrent glioblastoma: phase 1 trial interim results. Nat Med. 2024 May;30(5):1320-1329. doi: 10.1038/s41591-024-02893-z. Epub 2024 Mar 13.
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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 Cells in people with 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 12 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 13 Apr 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 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168423, which also lists 3 linked publications.
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 13 Apr 2026.