This is a Phase II open-label, two-arm randomised non-comparative, multi-centre study to evaluate the efficacy of Epcor-only (Epcoritamab alone) or Epcor-R2 (Epcoritamab, lenalidomide and rituximab) as consolidation post anti-CD19 CAR T-cell therapy for patients that have responded by conventional criteria but who are at high risk of progression by virtue of being Minimal Residual Disease (MRD) positive as determined by a Circulating Tumour DNA (ctDNA) assay.
Age ≥ 16 years old at the time of signing the patient information and consent form (PICF)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
A diagnosis of relapsed/refractory large B-cell lymphoma
Received Therapeutic Good Administration (TGA) approved anti-CD19 CAR T-cell therapy as the most recent large B-cell lymphoma treatment.
A history of Grade 4 CRS or ICANS related to prior CAR T-cell therapy
Patients whose lymphoma is known to be CD20 negative on the most recent biopsy prior to CAR T-cell therapy
Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment
Progression or relapse within 3 months after a regimen containing a bispecific antibody targeting CD3 and CD20
Parallel
Epcoritamab
DrugEpcoritamab will be administered as a 28-day cycle. In Cycle 1 and 2, epcoritamab will be given with step up dosing in Cycle 1. From Cycle 3 onwards dosing will be on Day 1 and 15 of each cycle.
Epcoritamab, lenalidomide and rituximab
DrugTreatment with epcoritamab will be administered following the same dosing schedule as Arm A. On days where rituximab and/or lenalidomide are also due, epcoritamab should be administered last. Patients will receive lenalidomide once daily on Day 1-21 of each 28-day cycle, starting at Cycle 1 through to Cycle 6. Patients will receive rituximab administered by intravenous (IV) infusion on Day 1, 8, 15 and 22 of Cycle 1 and on Day 1 only of Cycles 2-6.
The efficacy of Epcor-only (epcoritamab alone) or Epcor-R2 (epcoritamab, lenalidomide and rituximab) consolidation as assessed by conventional (Lugano 2014) response criteria at month 12 after the CART infusion
To evaluate the safety of time-limited Epcor-only or Epcor-R2 consolidation post CAR T-cell therapy according to number of participants with treatment-related adverse events (AE) as assessed by CTCAE v5.0
The efficacy as assessed by molecular and conventional response criteria at defined time points with Event Free Survival (EFS) analyses
The efficacy as assessed by molecular and conventional response criteria at defined time points with Overall Survival (OS) analyses
The deliverability as assessed by rates of completion of the course of therapy
Correlation between tumour/immunological associations (using cytokine/chemokine profiles, clonal kinetics and phenotypic changes) and response (EFS and OS)
Correlation between tumour/immunological associations (using cytokine/chemokine profiles, clonal kinetics and phenotypic changes) and treatment toxicity (number of participants with treatment-related AE)
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Peter MacCallum Cancer Centre, Australia
Lead sponsor
AbbVie
Collaborator
