Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER)

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07548450
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Waldenstrom Macroglobulinemia

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    200 mg daily
  • Mosunetuzumab — DRUG
    Administered subcutaneously on day one of applicable cycles.

Study Details

The purpose of this clinical trial it to test the safety and tolerability of the study drugs mosunetuzumab in combination with pirtobrutinib in patients with relapsed or refractory Waldenstrom's Macroglobulinemia.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2034
Completion
Jun 30, 2035

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dosing Strategy 1-Mosunetuzumab and Pirtobrutinib
    Participants receive pirtobrutinib daily on days 1-21 of 21 day cycles. Mosunetuzumab will be administered subcutaneously starting on cycle 2, day 1. If patients have a complete response to treatment, after 9 cycles, they will continue with on pirtobrutinib for a total of 18 cycles. If patients receive a very good partial or minor response, they will continue to receive Mosunetuzumab and Pirtobrutinib for a total of 18 cycles.
  • Experimental: Dosing Strategy 2- Mosunetuzumab and Pirtobrutinib
    Participants receive pirtobrutinib daily on days 1-21 of 21 day cycles. Mosunetuzumab will be administered subcutaneously starting on cycle 3, day 1. If patients have a complete response to treatment, after 9 cycles, they will continue with on pirtobrutinib for a total of 19 cycles. If patients receive a very good partial or minor response, they will continue to receive Mosunetuzumab and Pirtobrutinib for a total of 19 cycles.

Primary Outcome Measure

The recommended phase 2 dose (RP2D) which will be determined based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period. [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at University of UtahSalt Lake CityUtah84112
David Samuel
[email protected]
801-587-4713

Find similar trials in Salt Lake City, UT

By research site
Huntsman Cancer Institute at University of Utah· Salt Lake City, UT

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