A Phase 1/2 interventional study of Mosunetuzumab (IV) and Tocilizumab in Follicular Lymphoma, sponsored by Hoffmann-La Roche. Active, not recruiting at 26 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment
This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of mosunetuzumab (Mosun) + lenalidomide (Len) (Mosun + Len) in participants with follicular lymphoma (FL). This study will also compare the pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity of IV mosunetuzumab + len vs subcutaneous (SC) mosunetuzumab + len.
932 studies on the registry are indexed under Lymphoma, Follicular; 236 are open to participants now.
This study's planned enrollment of 237 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Drug: Mosunetuzumab (IV) · Drug: Tocilizumab · Drug: Lenalidomide
Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward). Participants that have received complete metabolic response (CMR) or partial metabolic response (PMR) after 12 cycles of induction therapy with mosunetuzumab + lenalidomide will receive maintenance therapy with SC mosunetuzumab every 8 weeks (Q8W) for an additional 9 cycles.
Drug: Tocilizumab · Drug: Lenalidomide
Participants will receive treatment with IV mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Drug: Mosunetuzumab (IV) · Drug: Lenalidomide
Participants will receive treatment with SC mosunetuzumab plus lenalidomide for 12 cycles total (cycle length = 21 days for Cycle 1, 28 days from Cycle 2 onward)
Drug: Lenalidomide · Drug: Mosunetuzumab (SC)
Participants will receive IV mosunetuzumab as defined by the study protocol
Also known as: RO7030816
Participants will receive IV tocilizumab as needed for adverse reactions as defined by the study protocol
Also known as: RO4877533
Participants will receive oral lenalidomide as defined by the study protocol
Participants will receive SC mosunetuzumab as defined by the study protocol
Also known as: RO7030816
Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 2 Days 1-28 (cycle length = 28 days)
Percentage of Participants with Adverse Events
Time frame: From baseline to 90 days after the last dose of study drug
Cumulative Area under the Curve over Cycles 1-3 (AUC1-3) of Mosunetuzumab
Time frame: Day 1 - Day 78
Serum Trough Concentration at Steady State Approximated by Cycle 4 (Ctrough, c4) of Mosunetuzumab
Time frame: Day 106
Overall Response Rate (ORR) as Determined by the Independent Review Committee (IRC)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
Complete Response Rate (CRR) as determined by the investigator (non-randomized stage)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
CRR as determined by Independent Review Committee (IRC) (randomized stage)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
Objective Response Rate (ORR) as determined by the investigator (non-randomized stage)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
ORR as determined by IRC (randomized stage)
Time frame: Up to the end of Cycle 12 (cycle length = 28 days)
Duration of Response (DOR) as determined by the investigator (non-randomized stage)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, up to the end of Cycle 8 (cycle length = 28 days)
DOR as determined by IRC (randomized stage)
Time frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, up to the end of Cycle 8 (cycle length = 28 days)
Duration of Complete Reponse (DOCR) as determined by the investigator (non-randomized stage)
Time frame: From the first occurrence of a documented complete response (CR) to disease progression, relapse, or death from any cause, whichever occurs first, up to the end of Cycle 12 (cycle length = 28 days)
DOCR as determined by IRC (randomized stage)
Time frame: From the first occurrence of a documented complete response (CR) to disease progression, relapse, or death from any cause, whichever occurs first, up to the end of Cycle 12 (cycle length = 28 days)
Percentage of Participants with AEs (Arms A and B)
Time frame: From baseline to 90 days after the last dose of study drug
Minimum Serum Concentration (Cmin) of Mosunetuzumab
Time frame: At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)
Maximum Serum Concentration (Cmax) of Mosunetuzumab
Time frame: At pre-defined intervals from Cycle 1 Day 1 through follow up (2 years after last treatment)
Cumulative AUC Over Cycles 1-2 (AUCc1-2) of Mosunetuzumab (Arms A and B)
Time frame: Day 1 - Day 50
Serum Trough Concentration in Cycle 2 (Ctrough, c2) of Mosunetuzumab (Arms A and B)
Time frame: Day 50
AUC at Steady State (AUCss) (Arms A and B)
Time frame: Cycle 4 (cycle length = 28 days)
Percentage of Participants with ADAs to Mosunetuzumab
Time frame: At pre-defined intervals from baseline through follow-up (2 years after last treatment)
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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