The purpose of this clinical trial is to assess the safety and tolerability of ration therapy followed by receiving epcoritamab or glofitamab in patients with relapsed/refractory diffuse large B-cell lymphoma.
Participant aged ≥ 18 years
Relapsed or refractory disease with at least 2 prior systemic therapies
Must be a candidate for radiation therapy up to 20 Gy. Radiation therapy to up to 3 lesions will be permitted.
Must have at minimum two sites of evaluable disease per Lugano 2014, including one site that will not be irradiated as part of this study and has not received radiation therapy in the past.
Currently receiving any other approved or investigational therapy considered as a treatment for lymphoma with the exception of corticosteroids.
Progressive disease on prior CD20 x CD3 bispecific antibody
Prior systemic anti-cancer therapy which may have delayed treatment effects (e.g. immunotherapy) ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.
Single group
Epcoritamab
DrugEpcoritamab will be administered per standard of care.
Glofitamab
DrugGlofitamab will be administered per standard of care.
External Beam Radiation Therapy
RadiationParticipants will receive radiation therapy for 5 fractions completed on sequential days.
The rate of CRS and ICANS adverse events as measured by ASTCT criteria attributed to RT and epcoritamab or glofitamab therapy.
To assess the safety and tolerability of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL. The study proposes this combination is safe and feasible if ≤20% of patients experience grade 3 or 4 cytokine release syndrome (CRS) (≤2 of 10 patients) and (2) ≤10% of patients experience grade 3 or 4 immune effector cell-associated neurotoxicity (ICANS) (≤1 of 10 patients).
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity as defined by the NIH CTCAE, version 6.0 and ASTCT.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness as defined by the NIH CTCAE, version 6.0 and ASTCT.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration as defined by the NIH CTCAE, version 6.0 and ASTCT.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
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