A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05169515
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • SC Mosunetuzumab — DRUG
    Participants will receive SC mosunetuzumab for 12 cycles (cycle length = 21 days or 28 days for Cycle 1 and 28 days for Cycles 2-12)
  • IV Glofitamab — DRUG
    Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
  • Iberdomide — DRUG
    Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12)
  • Golcadomide — DRUG
    Arm 1: Participants will receive oral golcadomide from Day 1-14 starting in either Cycle 1 or Cycle 2 through Cycle 12 (cycle length = 28 days for cycles when golcadomide is to be administered) Arm 2: Participants will receive oral golcadomide from Day 1-10 starting in either Cycle 1, Cycle 2 or Cycle 3 through Cycle 12 (cycle length = 21 days)
  • Obinutuzumab — DRUG
    Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
  • Tocilizumab — DRUG
    Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)

Study Details

This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and/or CC-99282) in participants with B-cell NHL.

Key Dates

Start date
Oct 26, 2022
Status verified
May 2026
Primary completion
Sep 15, 2029
Completion
Sep 15, 2029

Study Design

Enrollment
121 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants will receive subcutaneous (SC) mosunetuzumab + CC-220 (dose escalation only) or SC mosunetuzumab + CC-99282.
  • Experimental: Arm 2
    Participants will receive intravenous (IV) glofitamab + CC-99282.

Primary Outcome Measure

Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation] [ Time Frame: Until 90 days after the final dose of study treatment ]

Central Contacts

  • Reference Study ID Number: CO43805 https://forpatients.roche.com/
    888-662-6728
    [email protected]

Locations (6)

FacilityCityStateZIPSite coordinators
UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) ProgramSan FranciscoCalifornia94143-
University of ColoradoAuroraColorado80045-
Moffitt Cancer CenterTampaFlorida33612-
The University of ChicagoChicagoIllinois60637-
Levine Cancer InstituteCharlotteNorth Carolina28204-
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in San Francisco, CA

By research site
UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program· San Francisco, CAUniversity of Colorado· Aurora, COMoffitt Cancer Center· Tampa, FLThe University of Chicago· Chicago, ILLevine Cancer Institute· Charlotte, NCUT MD Anderson Cancer Center· Houston, TX

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