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

Who is this study for? Patients with B-cell non-Hodgkin lymphoma
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 DLBCL/transformed FL must have relapsed after or failed to respond to at least one prior systemic treatment regimen.

• Participants with DLBCL/transformed FL who have received only one prior line of therapy must: Not be considered a candidate for autologous stem cell transplantation (ASCT) due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT; or be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) therapy due to reasons defined by the protocol

• Fluorodeoxyglucose-avid lymphoma (i.e. PET-positive lymphoma)

• At least one bi-dimensionally measurable nodal lesion (\> 1.5 cm in its largest dimension by diagnostic quality CT or PET/CT scan), or at least one bi-dimensionally measurable extranodal lesion (\> 1.0 cm in its largest dimension by diagnostic quality CT or PET/CT scan)

• Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of NHL

• A fresh pretreatment biopsy during screening period, excisional or incisional, is preferred

• Adequate hematologic function without growth factors or blood product transfusion within 14 days of first dose of study drug administration

• Normal laboratory values

• All participants and health care providers will be trained and counseled on pregnancy prevention. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 3 months after the final dose of mosunetuzumab, at least 18 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC-99282, 3 months after the last dose of tocilizumab (if applicable), whichever is longer

• For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC- 99282, 2 months after the final dose of tocilizumab (if applicable), whichever is longer

Locations
United States
California
UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Aurora
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Illinois
The University of Chicago
RECRUITING
Chicago
North Carolina
Levine Cancer Institute
RECRUITING
Charlotte
Texas
UT MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Israel
Soroka
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Center Hospital
RECRUITING
Ramat Gan
Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna
RECRUITING
Bologna
ASST Spedali Civili di Brescia
RECRUITING
Brescia
IRCCS Istituto Romagnolo per lo studio dei tumori Dino Amadori
RECRUITING
Meldola
Irccs Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia
RECRUITING
Pisa
Spain
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
ICO L'Hospitalet
RECRUITING
L'hospitalet De Llobregat
Clinica Universidad de Navarra-Madrid
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hosp Universitario Salamanca
RECRUITING
Salamanca
Hospital Universitario La Fe
RECRUITING
Valencia
United Kingdom
NHS Greater Glasgow and Clyde
RECRUITING
Glasgow
University College London Hospitals
RECRUITING
London
Nottingham University Hospitals City Campus
RECRUITING
Nottingham
Oxford University Hospitals NHS Trust;Churchill Hospital
RECRUITING
Oxford
Contact Information
Primary
Reference Study ID Number: CO43805 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728
Time Frame
Start Date: 2022-10-26
Estimated Completion Date: 2029-03-07
Participants
Target number of participants: 121
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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