ArticleInternational journal of hematology2019
A multicenter phase I study of inebilizumab, a humanized anti-CD19 monoclonal antibody, in Japanese patients with relapsed or refractory B-cell lymphoma and multiple myeloma.
Article in International journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed.
- Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non-Japanese Individuals.Journal of clinical pharmacology · 2026Review
- Sequelae of B-Cell Depleting Therapy: An Immunologist's Perspective.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Review
- Immunotherapy in hematologic malignancies: achievements, challenges and future prospects.Signal transduction and targeted therapy · 2023Review
- Review
- Targeting CD19 in diffuse large B-cell lymphoma: An expert opinion paper.Hematological oncology · 2022Review
- Review
- Immunotherapeutic Strategies in Chronic Lymphocytic Leukemia: Advances and Challenges.Frontiers in oncology · 2022Review
- Immune targeted therapy for diffuse large B cell lymphoma.Blood science (Baltimore, Md.) · 2021Review
- Targeting Neuromyelitis Optica Pathogenesis: Results from Randomized Controlled Trials of Biologics.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021Review
- NK Cells in Chronic Lymphocytic Leukemia and Their Therapeutic Implications.International journal of molecular sciences · 2021Review
- Role of antibody-based therapy in indolent non-Hodgkin's lymphoma.Leukemia research reports · 2021Review
- New agents and regimens for diffuse large B cell lymphoma.Journal of hematology & oncology · 2020Review
- Current Immunotherapy Approaches in Non-Hodgkin Lymphomas.Vaccines · 2020Review
- Enhancing CDC and ADCC of CD19 Antibodies by Combining Fc Protein-Engineering with Fc Glyco-Engineering.Antibodies (Basel, Switzerland) · 2020Article
- Fc-Engineered Antibodies with Enhanced Fc-Effector Function for the Treatment of B-Cell Malignancies.Cancers · 2020Review
- Current and emerging therapeutics for neuromyelitis optica spectrum disorder: Relevance to the COVID-19 pandemic.Multiple sclerosis and related disorders · 2020Review
- Infectious Complications of Biological and Small Molecule Targeted Immunomodulatory Therapies.Clinical microbiology reviews · 2020Review
- Advances in targeted therapy for malignant lymphoma.Signal transduction and targeted therapy · 2020Review
- Immune Dysfunctions and Immune-Based Therapeutic Interventions in Chronic Lymphocytic Leukemia.Frontiers in immunology · 2020Review
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This multicenter, phase I, open-label dose escalation study evaluated safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of inebilizumab in Japanese patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), or multiple myeloma (MM) who were ineligible for hematopoietic stem cell transplantation. Patients received inebilizumab 2, 4, or 8 mg/kg intravenously on days 1 and 8 of the first 28-day cycle, and once every 28 days thereafter, with a 12 mg/kg cohort added. Twenty patients (11 FL, six DLBCL, two CLL, and one MM) received inebilizumab at four dose levels (2 mg/kg cohort, n = 3; 4 mg/kg cohort, n = 7; 8 mg/kg cohort, n = 4; 12 mg/kg cohort, n = 6). Three patients experienced dose-limiting toxicities: grade 4 neutropenia/grade 3 leukopenia (n = 1, 12 mg/kg) and grade 3 infusion reaction (n = 1 each, 4 mg/kg and 12 mg/kg); the maximum tolerated dose was 8 mg/kg. Four (three FL and one DLBCL) patients achieved complete response; eight (six FL and two DLBCL) achieved partial response. Overall response rate was 60%. Over the dose ranges evaluated, the pharmacokinetic profile of inebilizumab in Japanese patients was generally dose proportional. This phase I study showed acceptable toxicity and preliminary and promising efficacy of inebilizumab in patients with relapsed/refractory FL and DLBCL.
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Registered trials
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