🏛️ Verified NIH Record • Updated 2026-08-10
HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases (NCT03696030)
🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: City of Hope Medical Center
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial studies the side effects and best dose of HER2-CAR T cells in treating patients with cancer that has spread to the brain or leptomeninges and has come back (recurrent). HER2-CAR T cells delivered into the ventricles of the brain may recognize and kill tumor cells.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (41 items) and avoid the listed exclusions (18 items).
Location: City of Hope Medical Center — Duarte, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- EXCLUSION CRITERIA FOR STUDY SCREENING: Research participant requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks
- EXCLUSION CRITERIA FOR STUDY SCREENING: Research participants with a known history of congestive heart failure (CHF) or cardiac symptoms consistent with NYHA classification III-IV within 6 months prior to day 1 of protocol treatment, cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an EKG and echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment.
- Research participants with new symptoms of CHF, cardiomyopathy, myocarditis, MI, or exposure to cardiotoxic medications must have a cardiac consultation, creatinine phosphokinase (CPK), and troponin testing at pre study and as clinically indicated
- EXCLUSION CRITERIA FOR STUDY SCREENING: Research participant requires dialysis
- EXCLUSION CRITERIA FOR STUDY SCREENING: Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy
- EXCLUSION CRITERIA FOR STUDY SCREENING: Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase 1 study. A legal guardian may substitute for the research participant
- EXCLUSION CRITERIA FOR STUDY SCREENING: Participant is unwilling to stop treatment with chemotherapy or endocrine therapy during the first 3 cycles of the HER2-CAR T cell study
- EXCLUSION CRITERIA FOR STUDY SCREENING: Participant has a coagulopathy or bleeding disorder or cannot safely discontinue anticoagulation prior to placement of a Rickham reservoir
- EXCLUSION CRITERIA FOR STUDY SCREENING: Participant has a chronic or active viral infection of the CNS
- EXCLUSION CRITERIA FOR STUDY SCREENING: Participant has any uncontrolled illness, including ongoing or active infection; participant has known active hepatitis B or C infection; participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
- EXCLUSION CRITERIA FOR STUDY SCREENING: Participant is human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of screening
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- City of Hope Medical Center — Duarte, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.