Trial Profile
An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)
Status:
Active, no longer recruiting
Phase of Trial:
Phase I
Latest Information Update: 27 Mar 2024
Price :
$35
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At a glance
- Drugs Odronextamab (Primary) ; Odronextamab (Primary) ; Rituximab (Primary)
- Indications Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma; Waldenstrom's macroglobulinaemia
- Focus Adverse reactions; First in man; Proof of concept; Registrational; Therapeutic Use
- Acronyms ELM-1
- Sponsors Regeneron Pharmaceuticals
- 25 Mar 2024 According to a Regeneron Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy.
- 12 Dec 2023 Results of pooled analysis (n=507 from studies ELM-1 and ELM-2) assessing pharmacokinetics, pharmacodynamics, and exposure-response analyses for efficacy and safety of Odronextamab Monotherapy for the Treatment of Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and Diffuse Large B-Cell Lymphoma presented at the 65th American Society of Hematology Annual Meeting and Exposition
- 12 Dec 2023 Results (As of Dec 20, 2022, n=46 from a prespecified cohort of post CAR-T patients) assessing safety and efficacy of Odronextamab in Patients with Diffuse Large B-Cell Lymphoma presented at the 65th American Society of Hematology Annual Meeting and Exposition