Diffuse Large B Cell LymphomaPhase 1REBELNCT07528352
External Beam Radiotherapy Followed by Bispecific Antibody Therapy for Relapsed/Refractory DLBCL
A Phase 1 study testing Epcoritamab, Glofitamab and External Beam Radiation Therapy in people with Diffuse Large B Cell Lymphoma, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Epcoritamab, Glofitamab and External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Jun 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- --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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
David Samuel, 801-587-4713, David.samuel@hci.utah.edu
Allison Bock, MD
About this study
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
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
- Being tested
- Epcoritamab, Glofitamab, External Beam Radiation Therapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabDrug
Epcoritamab will be administered per standard of care.
GlofitamabDrug
Glofitamab will be administered per standard of care.
External Beam Radiation TherapyRadiation
Participants will receive radiation therapy for 5 fractions completed on sequential days.
| Study group | Role | What they receive |
|---|---|---|
| Radiation followed by bispecific antibody therapy | 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). Receives: Drug: Epcoritamab; Drug: Glofitamab; Radiation: External Beam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (7)
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.
Measured: 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.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
Measured: 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.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
Measured: 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.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
Measured: 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.
To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (Epcoritamab or Glofitamab) in patients with R/R DLBCL.
Measured: 18 months
Complete response rate (CRR), defined as the proportion of participants achieving a confirmed CR as defined by Lugano 2014 response criteria.
To assess the complete response rate (CRR) in the study population.
Measured: 18 months
Objective response rate (ORR), defined as the proportion of participants achieving a confirmed PR and CR as defined by Lugano 2014 response criteria.
To assess the objective response rate (ORR) in the study population.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jun 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528352
- Sponsor's protocol ID
- HCI198128
- Acronym
- REBEL
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07528352
- Acronym / sponsor ID
- REBEL / HCI198128
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation followed by bispecific antibody therapy | Experimental | Drug: Epcoritamab, Drug: Glofitamab, Radiation: External Beam Radiation TherapyThis study will investigate the safety and tolerability of 5 days of radiation therapy followed directly by a bispecific antibody therapy (Epcoritamab or Glofitamab). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Participant aged ≥ 18 years
- Disease criteria:
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpcoritamabEpcoritamab will be administered per standard of care. | Drug | Radiation followed by bispecific antibody therapy |
| GlofitamabGlofitamab will be administered per standard of care. | Drug | Radiation followed by bispecific antibody therapy |
| External Beam Radiation TherapyParticipants will receive radiation therapy for 5 fractions completed on sequential days. | Radiation | Radiation followed by bispecific antibody therapy |
Primary outcome
The rate of CRS and ICANS adverse events as measured by ASTCT criteria attributed to RT and epcoritamab or glofitamab therapy.
Time frame: 18 months
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).
7 secondary outcomes
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
Complete response rate (CRR), defined as the proportion of participants achieving a confirmed CR as defined by Lugano 2014 response criteria.
Time frame: 18 months
Objective response rate (ORR), defined as the proportion of participants achieving a confirmed PR and CR as defined by Lugano 2014 response criteria.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epcoritamab, Glofitamab and External Beam Radiation Therapy in people with Diffuse Large B Cell Lymphoma, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Samuel (801-587-4713, david.samuel@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of CRS and ICANS adverse events as measured by ASTCT criteria attributed to RT and epcoritamab or glofitamab therapy. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.