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Be Part of Research - Trial Details - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Stopped

Open to: ALL

Age: 18.0 - N/A

Leicester

Medical Conditions

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a first-in human, open-label, Phase 1 dose-escalation study in order to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for intravenous (IV) and/or subcutaneous (SC) dosing schemes of this combination treatment, and to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of this combination treatment in participants with relapsed/refractory B-cell non Hodgkin lymphoma (r/r NHL).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2022 Jul 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : RO7443904 will be administered by subcutaneous (SC) or IV infusion on Cycle (C) 1 Day (D) 10, C2D3, and C2D8. From C3 onward, RO7443904 will be given every 3 weeks (Q3W), for up to 12 cycles (C = 21 days).

Intervention Arm Group : Part IV: Dose-expansion of RO7443904;Parts I-III: Dose-escalation of RO7443904;

Intervention Type : DRUG
Intervention Description : Glofitamab will be administered through IV infusion starting with step-up dosing (2.5 mg/10 mg/30 mg) on C1D1, C1D8, and C2D1. Starting in Cycle 3, glofitamab will be given in 30 mg doses every three weeks (Q3W) with RO7443904, for up to 12 cycles (Cycle = 21 days).

Intervention Arm Group : Part IV: Dose-expansion of RO7443904;Parts I-III: Dose-escalation of RO7443904;

Intervention Type : DRUG
Intervention Description : Obinutuzumab will be administered once through IV infusion, at a 1 g dose in Cycle 1, on either Day -7, -4, or -3 (C1D-7, C1D-4, C1D-3).

Intervention Arm Group : Parts I-III: Dose-escalation of RO7443904;

Intervention Type : DRUG
Intervention Description : Tocilizumab will be administered as necessary to treat cytokine release syndrome (CRS).

Intervention Arm Group : Part IV: Dose-expansion of RO7443904;Parts I-III: Dose-escalation of RO7443904;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Leicester Royal Infirmary; Dept of Haematology
    Leicester
    LE1 5WW


The study is sponsored by Hoffmann-La Roche



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Read full details for Trial ID: NCT05219513
Last updated 22 August 2024

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