Actively Recruiting
Hypofractionation Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse B-cell Lymphoma With Baseline High Tumor Burden
Led by Liling Zhang · Updated on 2026-05-14
40
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Glofitamab has shown efficacy and safety in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and has been approved for marketing in China. However, in patients with baseline high tumor burden, the complete response (CR) rate is relatively lower compared with patients without. There is still a need to improve the efficacy of glofitamab in patients with high tumor burden. Previous studies have shown that hypofractionation radiotherapy (HRT) may induce T cell immune responses and improve the tumor microenvironment . Evidence shows that radiotherapy (RT) improves chimeric antigen receptor T-cell (CAR-T) efficacy as a bridging therapy . Based on the experience of RT combined with CAR-T, bispecific antibodies, as another T-cell therapy, may also demonstrate synergistic effects when combined with HRT, especially in those patients with bulky disease. This study will enroll R/R DLBCL patients with high tumor burden to assess the efficacy and safety of glofitamab in combination with HRT and to explore a new treatment model for R/R DLBCL patients with high tumor burden at baseline.
CONDITIONS
Official Title
Hypofractionation Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse B-cell Lymphoma With Baseline High Tumor Burden
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Age between 18 and 75 years at consent.
- Expected survival of at least 12 weeks.
- ECOG performance status score of 0 to 2.
- Confirmed CD20-positive diffuse large B-cell lymphoma.
- Relapsed or refractory DLBCL with at least one prior systemic treatment including rituximab.
- Baseline high tumor burden defined as tumor diameter greater than 6 cm and/or total metabolic tumor volume over 128.7 mL.
- Negative HIV test at screening or stable HIV-positive patients on therapy with CD4 count at least 200/μL and undetectable viral load.
- Women of childbearing potential must have negative pregnancy test within 7 days before enrollment and agree to use effective contraception during treatment and follow-up.
You will not qualify if you...
- Allergy or metabolic disorder to study drugs.
- Previous allogeneic organ transplant.
- Systemic immunotherapy within 4 weeks or 5 half-lives before treatment.
- Anti-cancer drug treatment within 28 days before treatment start.
- Prior radiotherapy to mediastinum or pericardium.
- Severe or extensive cardiovascular disease.
- Major surgery within 4 weeks before treatment, excluding diagnostic surgeries.
- Active central nervous system lymphoma.
- Known or suspected hemophagocytic lymphohistiocytosis.
- Current or history of Waldenström's macroglobulinemia.
- Active infection at enrollment.
- Severe immune-related adverse events from prior immunotherapy.
- History of autoimmune diseases except certain well-controlled conditions.
- Abnormal coagulation function (INR/PT >1.5x ULN, PTT/aPTT >1.5x ULN).
- Suspected or latent tuberculosis.
- Active hepatitis B, positive hepatitis C RNA, or HIV seropositive.
- Previous invasive malignancies except certain early-stage cancers.
- Pregnant, breastfeeding, or planning pregnancy during study or specified risk periods.
- Other uncontrolled medical conditions affecting participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
L
Liling Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here