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Conference/Presentation Title: | A Phase 1 Dose Escalation Study of Igm-2323, a Novel Anti-CD20 x Anti-CD3 IgM T Cell Engager (TCE) in Patients with Advanced B-Cell Malignancies. | Authors: | Budde E.;Gopal A.K.;Kim W.S.;Flinn I.W.;Cheah C.Y.Y.;Nastoupil L.;Matasar M.J.;Diefenbach C.S.;Gregory G.P.;Qazi I.;Pang C.-F.;Leabman M.;Hernandez G.;Sison I.;Keyt B.A.;Chen D.;Armand P. | Institution: | (Gregory) School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia (Budde) T Cell Therapeutics Research Laboratory, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA, United States (Gopal) Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, University of Washington, Seattle, WA, United States (Kim) Hematology and Oncology, Department of Medicine, Samsung Medical Center, Seoul, South Korea (Flinn) Sarah Cannon Research Institute, Nashville, TN, United States (Cheah) Department of Haematology, NW Cancer Centre, Perth, Australia (Nastoupil) Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, United States (Matasar) Memorial Sloan Kettering Cancer Center, New York, NY, United States (Diefenbach) Perlmutter Cancer Center at NYU Langone Health, New York, NY, United States (Qazi, Leabman, Hernandez, Sison, Keyt, Chen) IGM Biosciences, Mountain View, CA, United States (Pang) Phi Consulting Group, Bellevue, WA, United States (Armand) Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States |
Presentation/Conference Date: | 5-Jan-2022 | Copyright year: | 2021 | Publisher: | Elsevier B.V. | Publication information: | Blood. Conference: 63rd ASH Annual Meeting. Atlanta United States. 138(Supplement 1) (pp 132), 2021. Date of Publication: 23 Nov 2021. | Abstract: | Introduction: IGM-2323 is the first engineered high-affinity, high-avidity bispecific IgM monoclonal antibody TCE to be tested in the clinic. It has 10 binding domains for CD20 and a single binding domain for CD3 and is designed to bind irreversibly to CD20-high and low-expressing cells with more physiologic stimulation to T cells, which may mitigate cytokine release syndrome (CRS)-related toxicity and broaden the therapeutic window. IGM-2323 may act by multiple mechanisms: T-cell dependent cytotoxicity, complement dependent cytotoxicity, and enhanced immune modulation via IFNgamma-dominant cytokine stimulation. This phase 1 study is exploring the safety and activity of IGM-2323 using a dose titration schedule intended to optimize repeatable immune stimulation while minimizing toxicity. Method(s): This first-in-human Phase 1 study is a global, multicenter, open-label, dose escalation evaluating safety, tolerability, PK, and preliminary efficacy (NCT04082936). Adults with relapsed or refractory CD20 + B-cell NHL with >= 2 prior systemic therapies, adequate organ function, and ECOG 0-1 are eligible. IGM-2323 is given IV on Days 1, 8, and 15 of 21-day cycles until disease progression or unacceptable toxicity. Treatment can continue beyond progression if the patient (pt) has benefitted from treatment and intra-patient dose escalation is allowed. This study also utilizes a dose titration scheme where a starting dose is given on Day 1, then higher subsequent doses...Copyright © 2021 American Society of Hematology | Conference Name: | 63rd ASH Annual Meeting | Conference Start Date: | 20211-2-11 | Conference End Date: | 20211-2-14 | Conference Location: | Atlanta, United States | DOI: | http://monash.idm.oclc.org/login?url=https://dx.doi.org/10.1182/blood-2021-153355 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/44609 | Type: | Conference Abstract | Subjects: | *advanced cancer B cell lymphoma *cancer patient cancer recurrence drug megadose drug safety drug therapy *drug tolerability immunostimulation phase 1 clinical trial *plasmacytoma systemic therapy *T lymphocyte titrimetry *CD20 antibody *CD3 antibody endogenous compound *immunoglobulin M |
Appears in Collections: | Conferences |
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