Trials / Active Not Recruiting
Active Not RecruitingNCT05207670
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies
An Open-Label, Multicenter, Phase II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Subcutaneous Mosunetuzumab Monotherapy in Patients With Select B-Cell Malignancies
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 320 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma \[NHL\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mosunetuzumab (Cohorts A-C) | Participants will receive SC mosunetuzumab for up to 17 cycles and for optional maintenance (Cohort A only) |
| DRUG | Mosunetuzumab (Cohorts D-E) | Participants will receive SC mosunetuzumab for up to 34 cycles |
| DRUG | Tocilizumab | Participants can be treated with tocilizumab if they present with CRS after receiving mosunetuzumab |
Timeline
- Start date
- 2022-02-01
- Primary completion
- 2028-07-31
- Completion
- 2028-07-31
- First posted
- 2022-01-26
- Last updated
- 2026-03-05
Locations
39 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05207670. Inclusion in this directory is not an endorsement.