Immune cells engineered to hunt two targets in brain cancer
NCT ID NCT05168423
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether specially engineered immune cells are safe and feasible for people with a recurring type of brain cancer called glioblastoma. The cells are designed to recognize and attack two specific proteins found on the cancer cells. The study involves 67 participants and focuses on side effects and manufacturing success, not yet on curing the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered immune cells (CART-EGFR-IL13Ra2) that target two proteins on cancer cells
- What this could lead to
- If it works, this could point toward a new treatment option for recurrent glioblastoma, a brain cancer with few effective therapies.
- What could go wrong
- This is an early Phase 1 trial focused on safety, not yet on effectiveness. The treatment may cause serious side effects, and many experimental cell therapies fail to show benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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67 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Dec 2039
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed, written informed consent 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 radiotherapy. For patients with tumors harboring methylation of the MGMT promoter, at least 12 weeks 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 or tumor biopsy to confirm tumor recurrence 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 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). 3. Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA 4. 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. Exclusion Criteria: 1. Active hepatitis B or hepatitis C infection. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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