External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL

NCT07528352 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HCI198128
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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. We propose 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).

  18 months

Secondary Outcomes (7)

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.

  18 months

• 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.

  18 months

• 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.

  18 months

• 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.

  18 months

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by the relationship to study treatment as defined by the NIH CTCAE, version 6.0 and ASTCT.

  18 months

Study Arms (1)

All patients

EXPERIMENTAL

This study will investigate the safety and tolerability of 5 days of radiation therapy followed directly by a bispecific antibody therapy (Epcoritamab or Glofitamab).

Drug: Epcoritamab; Drug: Glofitamab; Radiation: External Beam Radiation Therapy

Interventions

Epcoritamab DRUG

Epcoritamab will be administered per standard of care.

All patients

Glofitamab DRUG

Glofitamab will be administered per standard of care.

All patients

External Beam Radiation Therapy RADIATION

Participants will receive radiation therapy for 5 fractions completed on sequential days.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant aged ≥ 18 years
• Disease criteria:
• Histologically confirmed large b-cell lymphoma (LBCL), including DLBCL not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma with:
• 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.
• ECOG Performance Status ≤ 3
• Adequate organ function as defined as
• Hematologic:
• Absolute neutrophil count ≥ 1000/mm3 (Note: Use of G-CSF is permitted)
• Platelet count ≥ 50,000/mm3 (Note: Use of platelet transfusions is permitted)
• Hemoglobin ≥ 7 g/dL, (Note: Blood transfusions are permitted)
• Hepatic:
• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
• AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Participants with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.

You may not qualify if:

• 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
• Note: Prior therapy with CD20 x CD3 bispecific antibody is allowed.
• 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.
• Known brain metastases or cranial epidural disease.
• Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry
• Significant medical diseases or other conditions, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study.
• Active systemic bacterial, viral, fungal or other infection requiring systemic treatment at time of screening.
• Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
• Note: Participants on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
• Hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
• Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
• Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
• Unable to tolerate corticosteroids

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

glofitamab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

David Samuel

CONTACT

801-587-4713; david.samuel@hci.utah.edu

Allison Bock, MD

CONTACT

801-585-0255; Allison.Bock@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)