ISRCTN17975931进行中（未招募）1 期
A Phase Ib, open-label, dose-escalation, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of subcutaneous glofitamab following obinutuzumab pretreatment in patients with relapsed or refractory B-cell non-Hodgkin lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
进行中（未招募）
1 期
A Phase IIa, open-label, dose-titration, multicentre study to assess the safety and preliminary efficacy of NI-0401 in patients with acute cellular renal allograftt rejectioEUCTR2007-001857-24-GBovImmune S.A.12
进行中（未招募）
1 期
A Phase IIa, open-label, dose-titration, multicentre study to assess the safety and preliminary efficacy of NI-0401 in patients with acute cellular renal allograftt rejectioEUCTR2007-001857-24-FRovImmune S.A.12
进行中（未招募）
1 期
A Phase IIa, open-label, dose-titration, multicenter study to assess the safety and preliminary efficacy of NI-0401 in patients with acute cellular renal allograftt rejectioAcute cellular renal allograft rejection.EUCTR2007-001857-24-PLovImmune S.A.12
进行中（未招募）
1 期
A study to evaluate the safety, tolerability, processing by the body, and antitumor activity of inavolisib and paclitaxelSolid tumors, Breast cancerMalignant neoplasm of breastCancerISRCTN45319897Genentech, Inc104
进行中（未招募）
1 期
A study with INC280 in combination with cetuximab in selected patients with colorectal or head and neck cancer who have progressed on prior therapyEUCTR2014-000579-20-ITOVARTIS FARMA60