Engineered immune cells take on recurrent brain tumors in early trial
NCT ID NCT07209241
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This early-phase study tests a new treatment for a type of brain cancer (glioblastoma) that has come back after standard therapy. The treatment uses the patient's own immune cells, which are modified in a lab to recognize and attack the cancer. The main goal is to check the safety of this approach in 12 adults whose tumors have a specific genetic change (EGFR amplification).
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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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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Nov 2042
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 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: 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
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Other studies related to the condition(s) this trial covers.
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