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Monoclonal Antibodies

RO7443904 + Glofitamab for Non-Hodgkin's Lymphoma

Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight >=40 kg
Able and willing to provide a fresh tumor biopsy from a safely accessible site, per Investigator's determination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights

Study Summary

This trial is testing a new combination treatment for people with relapsed/refractory B-cell non Hodgkin lymphoma. The goal is to find the maximum tolerated dose and evaluate safety and preliminary anti-tumor activity.

Who is the study for?
This trial is for adults with B-cell Non-Hodgkin's Lymphoma that has come back or didn't respond to at least two treatments, and there are no other beneficial treatments available. Participants must weigh at least 40 kg, have a measurable tumor lesion, be able to provide a biopsy, not have active infections or certain health conditions, and agree to contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of RO7443904 combined with Glofitamab in patients with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. It aims to find the highest dose patients can tolerate without severe side effects (MTD) and recommends doses for future studies (RP2D).See study design
What are the potential side effects?
Possible side effects include reactions related to infusion such as fever or chills, organ inflammation, increased risk of infection due to immune system suppression, fatigue, allergic reactions similar to previous monoclonal antibody therapies they may have had.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 40 kg.
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I can provide a new tumor sample from a safe location.
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I am a man and will use birth control during and after treatment as required.
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I am fully active or can carry out light work.
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My blood cancer is resistant to at least two treatments and lacks other beneficial treatment options.
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I am not pregnant or breastfeeding and agree to use birth control or abstain from sex as required.
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My doctor expects me to live for at least 12 more weeks.
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My liver, blood, and kidney functions are all within normal ranges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence, nature, and severity of AEs
Nature and frequency of dose-limiting toxicities (DLTs)
Secondary outcome measures
Area under the curve (AUC) of RO7443904
Clearance (CL) of RO7443904
Half-life (t1/2) of RO7443904
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Parts I-III: Dose-escalation of RO7443904Experimental Treatment4 Interventions
The dose-escalation of RO7443904 and glofitamab will take place every three weeks (Q3W) with obinutuzumab pre-treatment.
Group II: Part IV: Dose-expansion of RO7443904Experimental Treatment3 Interventions
Part IV of this study will evaluate selected dose levels of RO7443904 in combination with glofitamab from Parts I-III in a Q3W regimen with obinutuzumab pre-treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Obinutuzumab
2015
Completed Phase 3
~3250
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,088,951 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,379 Total Patients Enrolled

Media Library

Glofitamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05219513 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Parts I-III: Dose-escalation of RO7443904, Part IV: Dose-expansion of RO7443904
Non-Hodgkin's Lymphoma Clinical Trial 2023: Glofitamab Highlights & Side Effects. Trial Name: NCT05219513 — Phase 1
Glofitamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05219513 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted approval for Parts I-III: Dose-escalation of RO7443904?

"Our team at Power gave RO7443904 a rating of 1 on the safety scale since this is only Phase 1, meaning there is scant evidence indicating its effectiveness and limited data to suggest that it's safe."

Answered by AI

How many subjects are enrolled in this experiment?

"Affirmative. Clinicaltrials.gov information affirms that this clinical trial is currently enrolling patients, which began on February 18th 2022 and was last modified on November 16th 2022. The study requires 200 participants to be recruited from 2 distinct sites."

Answered by AI

Are there any available vacancies in this clinical trial?

"As per clinicaltrials.gov, this experiment is presently enrolling individuals. It was first advertised on February 18th 2022 and its most recent update occurred on November 16th 2022."

Answered by AI
~68 spots leftby Apr 2025