Trial to Evaluate Efficacy and Safety of Subcutaneous Mosunetuzumab in Previously Untreated Low Tumor Burden Follicular Lymphoma .

Sponsor
Tel-Aviv Sourasky Medical Center
Study ID
NCT07191249
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a multi-center, open-label, interventional clinical trial designed to evaluate the efficacy and safety of subcutaneous (SC) Mosunetuzumab as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTB-FL), defined by the absence of GELF criteria.

Key Dates

First listed
Sep 24, 2025
Start date
Jan 5, 2026
Status verified
Sep 2025
Primary completion
Apr 1, 2028
Completion
Mar 1, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with follicular lymphoma with low tumor burden who have not been previously treated
    In this study, Mosunetuzumab will be administered subcutaneously over 8 treatment cycles: 5 mg on Day 1 of Cycle 1, followed by 45 mg in all subsequent cycles.

Primary Outcome Measure

Overall Response Rate-ORR Overall response rate (ORR) at the end of treatment (6 months) using the Lugano criteria [ Time Frame: 6 months ]

Central Contacts

Related Studies