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)
Single group
zamtocabtagene autoleucel (MB-CART2019.1)
Biological/Vaccinechimeric antigen receptor T-cell (CAR-T) therapy
Cyclophosphamide
DrugLymphodepleting chemotherapy
Fludarabine
DrugLymphodepleting chemotherapy
Progression-free survival (PFS)
The primary endpoint is PFS at 1-year following MB2019.1 CAR T cell infusion. PFS is defined as the time interval from CAR T cell infusion until a PFS event occurs.
Treatment Response
Treatment response will be assessed using Lugano Criteria (Cheson et al, 2014). Both best overall response and Day 90 response following CAR T cell infusion will be evaluated.
Overall Survival (OS)
Events for OS include deaths from any cause. OS is defined as the time interval from CAR T cell infusion until death.
Duration of Complete Response (DOCR)
DOCR is defined as the time from a participant's first achieving a CR until either a disease progression occurs per 2014 Lugano or IPCG criteria or death, whichever occurs first. DOCR will be evaluated in the set of participants who achieve a CR.
Non-relapse Mortality (NRM)
Events for NRM include deaths without prior relapse/progression of the underlying malignancy. Relapse/progression is treated as a competing risk for NRM.
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Miltenyi Biomedicine GmbH
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
National Cancer Institute (NCI)
Collaborator
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