Phase 3 study to Compare T-Guard to Ruxolitinib for SR-aGVHD patients.

  • Research type

    Research Study

  • Full title

    A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare T-Guard to Ruxolitinib for the Treatment of Patients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD).

  • IRAS ID

    301767

  • Contact name

    Chloe Anthias

  • Contact email

    chloe.anthias@rmh.nhs.uk

  • Sponsor organisation

    Xenikos B.V.

  • Eudract number

    2021-000343-53

  • Clinicaltrials.gov Identifier

    NCT04934670

  • Duration of Study in the UK

    3 years, 0 months, 28 days

  • Research summary

    Research Summary:
    This is a Phase 3, open-label, randomised, international multicentre trial designed to compare T-Guard to ruxolitinib for the treatment of patients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD). Allogeneic Hematopoietic Cell Transplantation (allo-HSCT) is a potent immunotherapy with curative potential for several haematological disorders. Improvements in survival following allo-HSCT have led to its increasing use, but the leading cause of non-relapse mortality (NRM) remains Graft-Versus-Host Disease (GVHD). Serious infections and impairment of generalised immune function are responsible for GVHD mortality. The mainstay of treatment of acute GVHD (aGVHD) for over three decades has been high-dose corticosteroid. While steroids are considered first-line therapy for aGVHD, a significant fraction of the aGVHD population fail to have a clinical response, deeming them steroid-refractory (SR). In this proposed study, a new immunotoxin will be investigated in patients with Grade III/IV SRaGVHD and compared to ruxolitinib. This agent is attractive to study based on immunosuppressive profile and response rates reported on 20 patients in a Phase 1/2 clinical trial (Groth, van Groningen et al. 2017). Anti-CD3/anti-CD7 antibody treatment in patients with severe SR-aGVHD resulted in high day 28 CR rate of 50%, which compares favourably with historical controls (20-30%), and a high Day 180 OS. In addition, the short treatment course (4 treatments given every 48 hours) allows for a rapid response and fast restoration of the immune system due to the lack of ongoing exposure to immunosuppressive agents. In this study T-Guard will be compared to ruxolitinib. Both products will be supplied by the sponsor including protocol-specific dosing instructions.

    Summary of the Results:
    When the study was ended early, the Sponsor began reviewing the information collected which included an evaluation of the reason that the study was stopped. The sponsor created a report of the results. This is a summary of the overall results. The results might not be the same for each participant. Researchers look at results of many studies to decide which drugs work best and are safest for people living with aGVHD. Other trials may provide new information or different results.
    This trial compared the patients of the T-Guard treated group to the ruxolitinib treated group to see how many participants would have aGVHD go away completely 28 days after receiving the first dose of their assigned study drug. Two (2) of 7 (29%) participants who took T-Guard had their aGVHD go away. None (0 of 5) of the participants taking ruxolitinib had their aGVHD go away. This is a summary of some of the main results of this study. Other studies may have different results.
    The number of people who took part in the study was not large enough to show a real difference in outcomes between the groups. The differences could have happened by chance.

    How has this study helped patients and researchers?
    Findings from this trial may be used to plan additional trials using T-Guard or Ruxolitinib.

    Are there plans for further studies?
    No further clinical trials with T-Guard are planned at this time.

    Where can I learn more about this study?
    For more information about the results of your study, please speak with the study doctor or research staff at the trial site.

  • REC name

    South Central - Oxford B Research Ethics Committee

  • REC reference

    21/SC/0286

  • Date of REC Opinion

    3 Nov 2021

  • REC opinion

    Further Information Favourable Opinion