Non Hodgkin Lymphoma Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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, patients with R/R NHL who previously received at least two prior lines of systemic therapies can be enrolled. In the Dose Expansion phase, patients with FL (grade 1-3a), DLBCL/transformed FL who failed to respond to at least one prior line of systemic therapy can be potentially enrolled
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, 6 months and 2 weeks 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, 90 days after the last dose of CC-220, 3 months and 2 weeks after the last dose of CC- 99282, 2 months after the final dose of tocilizumab (if applicable), whichever is longer

Exclusion Criteria:

Pregnancy or breastfeeding, or intention of becoming pregnant during the study (female participants of childbearing potential must have a negative serum pregancy test result within 14 days prior to initiation of the study treatment)
Participant has received prior therapy with cereblon (CRBN)-modulating drug (e.g., lenalidomide, avadomide/CC-122, pomalidomide) Inability to swallow pills, or persistent diarrhea or malabsorption >= Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), despite medical management
QTc interval of > 470 ms
The following treatments prior to study entry: mosunetuzumab, glofitamab, or other CD20/CD3-directed bispecific antibodies; allogenic stem cell therapy (SCT); solid organ transplantation
Treatments (investigation or approved) within the following time periods prior to initiation/first dose of study treatment: radiotherapy within 2 weeks; autologous SCT within 100 days; chimeric antigen receptor (CAR) T-cell therapy within 30 days; prior anti-lymphoma treatment with monoclonal antibodies or antibody-drug conjugates within 4 weeks; use of radioimmunoconjugates within 12 weeks; systemic immunosuppressive medications within 2 weeks; any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter
Live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment
Current or past history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
Major surgery or significant traumatic injury < 28 days prior to enrollment (excluding biopsies) or anticipation of the need for major surgery during study treatment
Clinically significant toxicities from prior treatment have not resolved to Grade Evidence of any significant, concomitant disease (e.g. cardiovascular, pulmonary, liver, CVA or stroke, ILD, PML, infection, HLH etc) that could affect compliance with the protocol or interpretation of results
For participants enrolled into glofitamab cohort: documented refractoriness to an obinutuzumab monotherapy-containing regimen (defined as disease that did not achieve response (PR or CR) or progressed within 6 months of the last dose of an obinutuzumab-containing regimen)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

121

Study ID:

NCT05169515

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 25 Locations for this study

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UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
San Francisco California, 94143, United States
University of Colorado
Aurora Colorado, 80045, United States
The University of Chicago
Chicago Illinois, 60637, United States
UT MD Anderson Cancer Center; Investigational Pharmacy
Houston Texas, 77030, United States
Soroka
Be'er Sheva , 00841, Israel
Rambam Health Care Campus
Haifa , 31096, Israel
Hadassah Medical Center; Pulmonary Institute
Jerusalem , 91120, Israel
Center Hospital
Ramat Gan , 52621, Israel
Sourasky Medical Center; Oncology Department
Tel-Aviv , 64239, Israel
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna Emilia-Romagna, 40138, Italy
IRCCS Istituto Romagnolo per lo studio dei tumori "Dino Amadori"
Meldola Emilia-Romagna, 47014, Italy
ASST Spedali Civili di Brescia
Brescia Lombardia, 25123, Italy
Irccs Ospedale San Raffaele;U.O. Oculistica
Milano Lombardia, 20132, Italy
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia
Pisa Piemonte, 56126, Italy
ICO L'Hospitalet; Servicio de Farmacia
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Hospital Universitario La Fe; Hospital La Fe
València Valencia, 46026, Spain
Hospital Universitari Vall d Hebron
Barcelona , 08035, Spain
Clinica Universidad de Navarra-Madrid
Madrid , 28027, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28040, Spain
Hosp Universitario Salamanca
Salamanca , 37007, Spain
Western General Hospital; Edinburgh Cancer Center
Edinburgh , EH4 2, United Kingdom
NHS Greater Glasgow and Clyde; Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
University College London Hospitals
London , W1T 7, United Kingdom
Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team
Nottingham , NG5 1, United Kingdom
Oxford University Hospitals NHS Trust; Churchill Hospital; Clinical Trials Pharmacy Department
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

121

Study ID:

NCT05169515

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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