A Phase II Open-Label, Multi-Centre Study of Minimal Residual Disease-Directed Consolidation With Epcoritamab or Epcoritamab-Lenalidomide-Rituximab Post Anti-CD19 CAR TCell Therapy for Large B-Cell Lymphoma (EpLCART)
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.
• Partial metabolic response (PMR) or complete metabolic response (CMR) as per the Lugano criteria on the most recent PET/CT performed at any point between Day +25 and Day +100 post CAR T-cell infusion, when compared with the most recent PET/CT prior to CAR T-cell infusion.
• MRD positive by a ctDNA assay on a blood sample taken at any point between Day +25 and Day +100 post CAR T-cell infusion.
• Adequate haematological function documented within 7 days prior to randomisation
• Adequate cardiac function.
• Adequate renal function, documented within 7 days prior to randomisation
⁃ Adequate hepatic function documented within 7 days prior to randomisation
⁃ Complete resolution of cytokine release syndrome (CRS), macrophage-activation syndrome (MAS)/haemophagocytic lymphohistiocytosis (HLH) or immune effector cell-associated neurotoxicity syndrome (ICANS) related to prior CAR T-cell therapy.
⁃ Female patients of childbearing potential (FCBP) must be willing to follow the contraceptive method/procedure as outline in the PICF
⁃ Sexually active males must agree to use a condom during sexual contact with a pregnant female or a FCBP for the course of the study through to 4 months after the last dose of epcoritamab, even if he has undergone a successful vasectomy
⁃ Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction. Men must also not donate sperm during the trial and for 4 months after receiving the last dose of epcoritamab
⁃ The patient understands the purpose of the trial and procedures required for the trial which includes compliance with the protocol requirements and restrictions listed in the PICF and in this protocol