A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL) (NCT07137494) | Clinical Trial Compass
RecruitingPhase 1
A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)
United States12 participantsStarted 2025-08-14
Plain-language summary
This study will test whether MB-CART19.1 is a safe and effective treatment for central nervous system lymphoma (CNSL). This study will test different doses of MB-CART19.1 to find the highest dose that causes few or mild side effects in participants.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Men and women who are at least 18 years of age on the day of consenting to the study.
* Histologically documented primary or secondary central nervous system lymphoma of DLBCL subtype
* Relapsed/refractory primary or secondary CNSL patients. All relapsed//refractory patients need to have received at least one prior CNS-directed methotrexate-based therapy. There is no restriction on the number of recurrences.
* For relapsed patients, parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) within 21 days of study consent.
* For refractory patients, there must be residual disease after their last line of therapy.
* For patients with leptomeningeal disease only, CSF cytology and/or flow cytometry must document CSF findings consistent with CSF involvement by lymphoma and/or imaging findings consistent with CSF disease within 21 days of study registration (at the discretion of the investigator).
* Creatinine Clearance ≥ 40 ml/min/m2, direct bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x upper limit of normal (ULN)
* Adequate pulmonary function as assessed by ≥90% oxygen saturation on room air by pulse oximetry.
* Must be able to tolerate both MRI and CT scans
* Must be able to tolerate lumbar puncture and/or Ommaya taps
* Must have been either off corticosteroids, or on a stable or decreasing dose of dexamethasone equivalent ≤ 2 mg daily for 7 days before apheresis and 72 hours prior to CAR T cell infusi…