A study evaluating the effects of the body on and the safety and effectiveness of mosunetuzumab in patients with relapsed or refractory follicular lymphoma

Phase 1

• Conditions: Relapsed or refractory follicular lymphoma; Cancer; Follicular lymphoma

• Registration Number: ISRCTN49178226
• Lead Sponsor: Roche (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-08
• Last Update Posted: 19 December 2023
• Study Completion: 2025-04-21

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Age =18 years at the time of signing Informed Consent Form (ICF)
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
3. Histologically confirmed Grade 1-3a follicular lymphoma who have relapsed after or failed to respond to at least two prior lines of systemic therapy and must have received prior treatment with an anti-CD20-directed therapy and an alkylating agent
4. Participants must have a measurable disease: at least one bi-dimensionally measurable lesion (greater than 1.5 cm in its largest dimension for nodal lesions, or greater than 1.0 cm in its largest dimension for extranodal lesions)
5. Fluorodeoxyglucose (FDG)-avid lymphoma [i.e., positron emission tomography (PET) - positive lymphoma]
6. Adverse events from prior anti-cancer therapy resolved to = Grade 1 (with exceptions of alopecia and anorexia)
7. Residence in the People’s Republic of China

Exclusion Criteria

1. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable)
2. Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks before the first mosunetuzumab administration
3. Prior treatment with systemic immunotherapeutic agents for which the mechanism of action involves T cells within 12 weeks or five half-lives of the drug, whichever is shorter, before first Mosunetuzumab administration
4. Treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents (e.g., immune checkpoint inhibitor therapies)
5. Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first mosunetuzumab administration
6. Treatment with radiotherapy within 2 weeks prior to the first mosunetuzumab administration
7. Autologous stem cell transplant (SCT) within 100 days prior to first mosunetuzumab administration
8. Prior treatment with CAR-T therapy within 30 days before first Mosunetuzumab administration
9. Prior allogeneic SCT
10. Prior solid organ transplantation
11. History of autoimmune disease but participants with a remote history of, or well-controlled autoimmune disease may be eligible to enrol
12. Participants with a history of macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH)
13. Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
14. Current or past history of CNS lymphoma
15. Known or suspected chronic active Epstein-Barr Virus infection (CAEBV)

Study & Design

• Study Type: Interventional
• Study Design: Not specified