Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients with Relapsed or Refractory Multiple Myeloma - LINKER-MM1

Houvras Yariv0 个研究点目标入组 18 人开始时间: 2023年5月23日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•Eastern Cooperative Oncology Group (ECOG) performance status <= 1
•- Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
•- Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol.
•- Progression on or after at least 3 prior lines of therapy including a(n) protease inhibitor (PI), immunomodulatory agent (IMiD), and anti-cluster of differentiation 38 (CD38) antibody, OR
•- Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD. Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or less than 25% response to therapy.
•- Other protocol defined inclusion criteria apply

•- Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
•- Patients with known MM brain lesions or meningeal involvement
•-Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA)
•- Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs, and BCMA CAR T cells. Note: BCMA antibody-drug conjugates are not excluded
•- History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment
•- Other protocol defined exclusion criteria apply

发起方

Houvras Yariv