Radiation boosts new drug against tough lymphoma?
NCT ID NCT06867536
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding a short course of radiation to the drug glofitamab can help people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have large tumors. About 40 adults in China will receive glofitamab plus radiation. The main goal is to see how many achieve complete remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Glofitamab (a bispecific antibody) and hypofractionated radiotherapy
- What this could lead to
- If successful, this combination could improve complete remission rates for patients with hard-to-treat DLBCL who have large tumors.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply broadly. The added radiotherapy may increase side effects without clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent. * Aged 18-75 years at the time of signing the informed consent, willing to follow and able to complete all study procedures. * Expected survival ≥ 12 weeks. * ECOG performance status score of 0-2 points ; * Patients with CD20-positive DLBCL confirmed by pathological histology; (unspecified DLBCL, HGBCL, PMBCL, FL-transformed DLBCL). * R/R DLBCL who have received at least one line of systemic treatment (including at least 2 cycles of rituximab-containing immunochemotherapy). * Baseline high tumor burden, defined as tumor diameter \> 6 cm and/or TMTV \> 128.7 mL . * HIV test results were negative at screening, except for the following: HIV-positive patients who have been receiving stable antiretroviral therapy and CD4 count ≥ 200/µL before enrollment Patients with undetectable viral load can be enrolled. * Women of childbearing age with negative urine or blood pregnancy test within 7 days before enrollment need to agree to take effective contraceptive measures during treatment and follow-up. Exclusion Criteria: * Individuals who have drug allergies or metabolic disorders to the drugs in this protocol. * Previous recipients of allogeneic organ transplants. * Individuals who received systemic immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) of the drug. * Anti-cancer drug treatment within 28 days before the start of treatment * Prior radiotherapy in the mediastinum/pericardium area; radiation therapy for non-target lesion sites is allowed. * History of severe or extensive cardiovascular disease. * Recent major surgery (within 4 weeks before the start of Cycle 1), excluding diagnostic surgeries. * Currently suffering from active CNS lymphoma. * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Current or previous history of concurrent Waldenström's macroglobulinemia. * Known active infection at the time of enrollment in the study. * Immune-related adverse events that appeared during prior immunotherapy: ≥Grade 3 adverse events, except for Grade 3 endocrine diseases controlled by alternative therapies. Grade 1 or 2 adverse events that did not return to baseline levels after stopping treatment. * History of autoimmune diseases (long-standing or well-controlled autoimmune diseases, hypothyroidism, immune thrombocytopenic purpura, and well-controlled Type I diabetes are excluded). * Abnormal coagulation function: INR or PT \>1.5× upper limit of normal (ULN), PTT or aPTT \>1.5× ULN. * Suspected or latent tuberculosis (confirmed by positive IFNγ release test) * Active hepatitis B virus (HBV) infection/positive HCV RNA test for hepatitis C virus (HCV)/HIV seropositive. * Previously suffered from other invasive malignancies, excluding early-stage cervical cancer, basal cell carcinoma of the skin, and thyroid cancer . * Pregnant or breastfeeding, or planning to become pregnant during the study period or within 18 months after pre-treatment with obinutuzumab or within 2 months after the last dose of glofitamab (whichever is longer). * Other concurrent uncontrolled medical conditions that, in the investigator's opinion, would affect the patient's participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430022, China
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