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
Study Identifier:
BP43015
CT.gov Identifier:
N/A
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
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
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
N/A
Study Drug
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Participants who are age > or =18 years at the time of signing the Informed Consent Form
- Participants with a history or status of:
- A histologically confirmed hematological malignancy that is expected to express CD20
- No available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant [SCT])
- 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
- 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
- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants with life expectancy (in the opinion of the investigator) of > or =12 weeks
- Adverse events from prior anti-cancer therapy must have resolved to Grade 1 or better
- Participants with adequate liver, hematological and renal function
- Participants with a negative human immunodeficiency virus (HIV) and hepatitis C virus (HCV) test at screening
- Participants with a negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection
- 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
- 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
Exclusion criteria
- Participants who are unable to tolerate subcutaneous injection into the abdomen
- 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
- Participants who are unable to comply with protocol-mandated hospitalizations and restrictions
- Participants with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- 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
- 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
- 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
- Participants who were previously treated with CD20-CD3 bispecific antibodies (including glofitamab and mosunetuzumab), as this could influence the interpretation of pharmacokinetics and safety
- Participants with a history of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents
- 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
- Participants with prior solid organ transplantation
- Participants with prior allogeneic stem cell transplant (SCT)
- Participants with autologous SCT within 100 days prior to Gpt infusion
- Participants with a history of autoimmune disease
- Participants with a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy or recombinant antibody-related fusion proteins
- Participants with a history of confirmed progressive multifocal leukoencephalopathy
- Participants who currently have, or who have a history of, central nervous system (CNS) lymphoma
- Participants who currently have, or who have a history of, CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- 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
- 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
- Participants who have had another invasive malignancy in the last 2 years
- 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
- Participants who have received a live, attenuated vaccine within 4 weeks before Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study
- Participants who have received systemic immunosuppressive medications within 2 weeks prior to Gpt infusion
- Participants with a history of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator’s judgment
- Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
- Participants with a history of hypersensitivity to dexamethasone or systemic corticosteroids
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruiting
Condition(s) Treated at Site
Lymphoma, Non-Hodgkin's