Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM
NCT ID: NCT07209241
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2025-12-03
2042-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
* 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 are assigned sequentially, beginning with Arm A. Once Arm A is fully enrolled and all safety evaluations are complete, the data, along with cumulative data from other CART-EGFR-IL13Ra2 studies, will be reviewed by the Clinical Principal Investigator (PI) and Sponsor Medical Director to determine whether to open Arm B.
If it is decided not to progress to Arm B for any reason, Arm A will be expanded to include up to a total of eight evaluable subjects. Enrollment into Arm C begins only after Arms A and B (if applicable) are fully enrolled.
TREATMENT
NONE
Study Groups
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Arm A
Subjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion.
CART-EGFR-IL13Ra2 T cells
CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.
Arm B
Subjects will receive repeated dose administration of CART-EGFR-IL13Ra2 cells following lymphodepletion.
CART-EGFR-IL13Ra2 T cells
CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.
Arm C
Subjects will receive a single fixed-dose administration of CART-EGFR-IL13Ra2 in the pre-operative setting.
CART-EGFR-IL13Ra2 T cells
CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.
Interventions
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CART-EGFR-IL13Ra2 T cells
CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.
Eligibility Criteria
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Inclusion Criteria
2. Male or female age ≥ 18 years
3. 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.
4. 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.
5. 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.
6. Adequate organ function defined as:
1. Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 30 ml/min and not on dialysis.
2. ALT/AST ≤ 3 x ULN
3. Total bilirubin ≤ 2.0 mg/dL, except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome (≤ 3.0 mg/dL)
4. Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA
5. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
7. Karnofsky Performance Status ≥ 60%.
8. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3.
Exclusion Criteria
2. Any other active, uncontrolled infection.
3. Class III/IV cardiovascular disability according to the New York Heart Association Classification
4. Tumors primarily localized to the brain stem or spinal cord.
5. Severe, active co-morbidity in the opinion of the physician-investigator that would preclude participation in this study.
6. Receipt of bevacizumab within 3 months prior to physician-investigator confirmation of eligibility.
7. 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.
8. Patients who are pregnant or nursing (lactating).
9. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
18 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Stephen Bagley, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10325
Identifier Type: -
Identifier Source: org_study_id
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