FRONTIER is a prospective, single arm, open label, multi-center, Phase II study of MB-CART2019.1 (Zamtocabtagene Autoleucel) therapy as frontline consolidation for high-risk Mantle Cell Lymphoma (MCL) participants
Diagnosis of MCL requires histologic confirmation by either overexpression of cyclin D1 OR presence of t(11;14) (q13; q32) translocation
Subject should have a tumor biopsy sample (at least 5 unstained slides of tissue or tissue block) available prior to MB-CART2019.1 infusion, preferably collected pre-induction.
If archival tissue is not available, the patient may be enrolled after discussion with the protocol chair and/or protocol officer
High risk MIPI-c (as calculated by https://www.european-mcl.net/home/scores-mipi-mipi-c-19.html)
Unable to give informed consent
Any disease progression that occurs during the first 2 induction cycles
A creatinine clearance (as estimated by direct urine collection, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI], or Cockcroft-Gault Equation or institutional standard) < 45 mL/min
Cardiac ejection fraction (EF) < 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Acquisition scan (MUGA) (if range is provided, the upper value of the range may be used for assessing eligibility)
Miltenyi Biomedicine GmbH
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
National Cancer Institute (NCI)
Collaborator