A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Patients With B-Cell Non-Hodgkin Lymphoma
Hoffmann-La Roche
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>/= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * History of one of the following histologically documented hematologic malignancies that are expected to express the CD20 antigen: In the Dose Escalation phase, participants must have relapsed after or failed to respond to at least two prior lines of systemic therapy. In the Dose Expansion phase, participants with FL Grades 1-3a must have relapsed after or failed to respond to at least one prior line of systemic therapy and must require systemic therapy. Participants with DLBC…
Interventions
- DrugSC Mosunetuzumab
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)
- DrugIV Glofitamab
Participants will receive IV glofitamab for 12 cycles (cycle length = 21 days)
- DrugIberdomide
Arm 1: Participants will receive oral CC-220 from Day 1-21 of Cycle 2-12 (cycle length = 28 days for Cycles 2-12)
- DrugGolcadomide
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)
- DrugObinutuzumab
Participants in Arm 2 will receive pre-treatment with IV obinutuzumab on Cycle 1 Day 1 (cycle length = 21 days)
- DrugTocilizumab
Locations (26)
- UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) ProgramSan Francisco, California
- University of ColoradoAurora, Colorado
- Moffitt Cancer CenterTampa, Florida
- The University of ChicagoChicago, Illinois
- Levine Cancer InstituteCharlotte, North Carolina
- UT MD Anderson Cancer CenterHouston, Texas