A study to evaluate the safety, tolerability, processing by the body, mechanism of action, and effectiveness of glofitamab following obinutuzumab pretreatment in patients with B-cell non-Hodgkin lymphoma
- Conditions
- B-cell non-Hodgkin lymphomaCancerB-cell lymphoma, unspecified
- Registration Number
- ISRCTN17975931
- Lead Sponsor
- Genentech, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 36
1. Participants who are age =18 years at the time of signing the Informed Consent Form
2. Participants with a history or status of:
2.1. A histologically confirmed hematological malignancy that is expected to express CD20
2.2. No available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant [SCT])
3. Participants with measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extra-nodal lesion, defined as >1.0 cm in its longest dimension
4. Participants who are able to provide a fresh biopsy from a safely accessible site, per investigator determination, provided that the participant has more than one measurable target lesion
5. Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Participants with life expectancy (in the opinion of the investigator) of =12 weeks
7. Adverse events from prior anti-cancer therapy must have resolved to Grade 1 or better
8. Participants with adequate liver, hematological and renal function
9. Participants with a negative human immunodeficiency virus (HIV) and hepatitis C virus (HCV) test at screening
10. Participants with a negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection
11. For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for at least 18 months after the final dose of obinutuzumab, 3 months after the final dose of tocilizumab (if applicable), or 2 months after the final dose of glofitamab, whichever is longer
12. For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm during the treatment period and for at least 3 months after the final dose of obinutuzumab, tocilizumab (if applicable), or glofitamab, whichever is longer, to avoid exposing the embryo
1. Participants who are unable to tolerate subcutaneous injection into the abdomen
2. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after pretreatment with obinutuzumab or 2 months after the final dose of glofitamab, whichever is longer
3. Participants who are unable to comply with protocol-mandated hospitalizations and restrictions
4. Participants with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
5. Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab pretreatment (Gpt) infusion or by clinical judgment in the absence of a positive blood culture
6. Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
7. Participants who have had prior treatment with systemic immunotherapeutic agents within 4 weeks or five half-lives of the drug, whichever is shorter, before Gpt infusion on Day 1 of Cycle 1
8. Participants who were previously treated with CD20-CD3 bispecific antibodies (including glofitamab and mosunetuzumab), as this could influence the interpretation of pharmacokinetics and safety
9. Participants with a history of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents
10. Participants who have been treated with standard radiotherapy, any chemotherapeutic agent, any chimeric antigen receptor-modified T-cell (CAR-T) cell therapy, or any other investigational anti-cancer agent (defined as treatment for which there is currently no regulatory authority approved indication) within 4 weeks prior to Gpt infusion
11. Participants with prior solid organ transplantation
12. Participants with prior allogeneic stem cell transplant (SCT)
13. Participants with autologous SCT within 100 days prior to Gpt infusion
14. Participants with a history of autoimmune disease
15. Participants with a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy or recombinant antibody-related fusion proteins
16. Participants with a history of confirmed progressive multifocal leukoencephalopathy
17. Participants who currently have, or who have a history of, central nervous system (CNS) lymphoma
18. Participants who currently have, or who have a history of, CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
19. Participants with evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders (bronchospasm, obstructive pulmonary disease) and known autoimmune diseases
20. Participants who have undergone major surgery (excluding biopsies) or significant traumatic injury <28 days prior to the Gpt infusion or who anticipate the need for major surgery during study treatment
21. Participants who have had another invasive malignancy in the last 2 years
22. Participants who have significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
23. Participants who have rece
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method