HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases (NCT03696030) | Clinical Trial Compass
Active — Not RecruitingPhase 1
HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases
United States24 participantsStarted 2018-08-31
Plain-language summary
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 participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* SCREENING: Participant has treated brain and/or leptomeningeal metastases that has not recurred OR
* Such participants are eligible to enroll in the study and undergo leukapheresis, but they cannot start treatment with HER2-CAR T cells until there is evidence of tumor progression/recurrence
* SCREENING: Participant has recurrent brain metastases after radiation therapy OR
* SCREENING: Participant has recurrent leptomeningeal metastases after intrathecal chemotherapy OR
* SCREENING: Participant has untreated brain or leptomeningeal metastases and refuses to undergo radiation and/or intrathecal chemotherapy
* Note: Participants with leptomeningeal metastasis (diagnosed by positive CSF cytology or characteristic findings on brain or spine magnetic resonance imaging \[MRI\]) may have concomitant brain metastases, but having both is not required
* SCREENING: Participant must have a Karnofsky performance status (KPS) \>= 70
* SCREENING: Participant must have a life expectancy of \>= 8 weeks
* SCREENING: The effects of HER2-CAR T cells on a developing fetus are unknown. For this reason, women of child-bearing potential must have negative serum pregnancy test and agree to use a reliable form of birth control prior to study entry and for at least two months following duration of study participation. Male research participants must agree to use a reliable form of birth control and not donate sperm during the study and for at least six months afterwards
* SC…
What they're measuring
1
Incidence of dose limiting toxicities (DLTs)
Timeframe: 21 days post T cell infusion
2
Number of participants with treatment related adverse events