A Phase 1, Open-label, Dose Finding Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Subjects with Relapsed and Refractory Multiple Myeloma

JRCT ID: jRCT2051230108

Registered date:04/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed and refractory multiple myeloma
• Date of first enrollment: 16/10/2023
• Target sample size: 12
• Countries of recruitment: United States,Japan,Spain,Japan,Germany,Japan,Italy,Japan,Sweden,Japan
• Study type: Interventional
• Intervention(s): CC-93269

Outcome(s)

• Primary Outcome: To determine the safety and tolerability of CC-93269, in subjects with relapsed and refractory MM.
• Secondary Outcome: To evaluate the preliminary efficacy of CC-93269 in relapsed and refractory MM, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-History of multiple myeloma with relapsed and refractory disease
-Eastern Cooperative Oncology Group Performance Status of 0 or 1
-Must have measurable disease as determined by the central laboratory

Exclude criteria

-Symptomatic central nervous system involvement of multiple myeloma
-Prior autologous stem cell transplant <= 3 months prior
-Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning <= 12 months prior
-History of concurrent second cancers requiring active, ongoing systemic treatment

Related Information

• Primary Sponsor: Hayakawa Jin