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Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT07634289 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-08

No results posted yet for this study

Summary

The goal of this clinical trial is to see if a new combination of standard of care radiotherapy treatment prior to administering the study drugs obinutuzumab and glofitamab in relapsed/refractory Diffuse Large B Cell Lymphoma patients is effective. The main question it aims to answer is:

If you are able to tolerate the study treatments, and whether your cancer responds to the study treatment, compared with other reported studies of standard care treatments.

Participants will have three parts they need to complete over a 5 year period.

* Screening period over a 28 day period
* Treatment period - Radiotherapy followed by 12 treatment cycles every three weeks (total time approx. 37 weeks)
* Follow up, up to 4 years. Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 89Zr-Df-Crefmirlimab and 18F-Granzyme B for evaluation of the impact of radiotherapy plus glofitamab with relapsed diffuse large B-cell lymphoma.

Conditions

  • Relapsed /Refractory DLBCL

Interventions

DRUG

Glofitamab

Glofitamab is the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more prior systemic therapies.

RADIATION

Radiotherapy

25 Gy in 5 fractions.

DRUG

Obinutuzumab

Obinutuzumab as a pre-treatment to reduce the risk of CRS induced by glofitamab is approved in Australia.

OTHER

89Zr-Df-crefmirlimab

89Zr-Df-crefmirlimab infusion and imaging (24hrs+/- 4 hours) - must be at least 5 days prior to the first fraction of radiotherapy of study treatment, A second infusion of 89Zr-Df-crefmirlimab and imaging will be after Cycle 2 (15 days +/- 3 days)

OTHER

18F-granzyme B

Eligible participants will receive an initial injection of 18F-CSB-321 followed by PET imaging up to 14 days prior to commencing therapy. 370 MBq (±10%) of 18F-CSB-321 is injected, without the need of pre-medications. Participants will be monitored for adverse events up to 2 hours post-injection.

Sponsors & Collaborators

  • Fiona Stanley Hospital

    collaborator OTHER

  • Princess Alexandra Hospital, Brisbane, Australia

    collaborator OTHER

  • Austin Health

    collaborator OTHER_GOV

  • Townsville Hospital

    collaborator OTHER_GOV

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Flinders Medical Centre

    collaborator OTHER_GOV

  • Olivia Newton-John Cancer Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2031-12-31
Completion
2032-12-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634289 on ClinicalTrials.gov