External beam radiation followed by bispecific antibody therapy for relapsed or refractory DLBCL
Official title: REBEL: A Phase 1b Study on the Safety and Feasibility of External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL
Run by University of Utah · NCT07528352 · Data updated 2026-11-12
This study tests whether giving targeted radiation first, then bispecific antibodies (epcoritamab or glofitamab), is tolerable for adults with relapsed or refractory diffuse large B-cell lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, epcoritamab, glofitamab |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | June 2030 |
| Study ends | June 2031 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT07528352 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with relapsed or refractory LBCL/DLBCL who have received at least two prior systemic therapies and are candidates for up to 20 Gy of radiation to up to three lesions, with at least two evaluable disease sites including one not slated for radiation.
✕Probably not a fit
Patients whose disease does not respond to radiation or bispecific antibody therapy, or those with insufficient organ function or performance status, may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1 trial evaluates safety and tolerability of external beam radiation therapy up to 20 Gy followed by bispecific antibody therapy in adults with relapsed or refractory diffuse large B-cell lymphoma. Participants must have at least two sites of disease and at least one site non-irradiated, with prior systemic therapy. The study allows radiation to up to three lesions and requires adequate organ function. Epcoritamab or glofitamab will be used as the bispecific antibody therapy after radiation, to assess feasibility in this combination approach. Conducted at Huntsman Cancer Institute, University of Utah, the trial is led by a single sponsor with no listed collaborators.
Why it matters
Potential benefit: If successful, the approach could offer a new treatment sequence that may control disease with manageable safety in relapsed/refractory DLBCL.
How similar studies have gone: Prior studies of combining radiotherapy with bispecific antibodies in B-cell lymphomas have shown feasibility, but this exact sequence and combination are investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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.
--Renal:
* Estimated creatinine clearance ≥ 40 mL/min by Cockcroft-Gault formula.
* Participants must adhere to the following sex and contraceptive/barrier requirements:
* If participant is of childbearing potential they must have a negative pregnancy test
* For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* \< 50 years of age: ---Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
* Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution --≥ 50 years of age:
* Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
* Had radiation-induced menopause with last menses \>1 year ago; or
* Had chemotherapy-induced menopause with last menses \>1 year ago
* Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
* Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and lactation requirements as described in Sections 5.4.1 and 5.4.2.
* Clinically significant adverse effects from any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the Investigator.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
* 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
* Participants taking prohibited medications as described in Section 6.6.1.
Where it's running
-
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: David Samuel
- Email: david.samuel@hci.utah.edu
- Phone: 801-587-4713
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.