Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT06492837
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Mosunetuzumab in combination with Zanubrutinib — DRUG
    Combinations of Mosunetuzumab and Zanubrutinib as salvage strategy in patients with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Study Details

This is a Phase 2, multicenter study evaluating the efficacy and safety of mosunetuzumab + zanubrutinib (M+Z) used as salvage strategy in patients with R/R FL who have received at least one line of prior systemic therapy.

Key Dates

Start date
Oct 23, 2024
Status verified
Jan 2026
Primary completion
Sep 15, 2028
Completion
Sep 15, 2033

Study Design

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

Arms

  • Experimental: Mosunetuzumab in combination with Zanubrutinib
    Pre-phase: Zanubrutinib 320 mg daily by mouth (D-15 to D-1) Induction phase cycle 1 (Q21 days): * Zanubrutinib 320 mg daily by mouth (D1-21) * Mosunetuzumab 5 mg, SC (D1) * Mosunetuzumab 45 mg, SC (D8) * Mosunetuzumab 45 mg, SC (D15) Induction phase cycles 2-12 (Q28 days): * Zanubrutinib 320 mg daily by mouth (D1-28) * Mosunetuzumab 45 mg, SC (D1) Maintenance phase cycles 13-24 (Q28 days): Zanubrutinib 320 mg daily by mouth (D1-28) Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events.

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: 36 months ]

Central Contacts

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