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
Peter MacCallum Cancer Centre, Australia
Lead sponsor
AbbVie
Collaborator