Multiple Myeloma Clinical Trial
Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
Summary
Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.
Full Description
The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 5 years for subjects maintaining clinical benefit, or until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.
Eligibility Criteria
Inclusion 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
Exclusion 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
Other protocol-defined inclusion/exclusion criteria apply
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There are 34 Locations for this study
Birmingham Alabama, 35294, United States
San Francisco California, 94143, United States
New Haven Connecticut, 06510, United States
Atlanta Georgia, 30322, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48202, United States
New York New York, 10019, United States
Seattle Washington, 98104, United States
Erlangen , 91054, Germany
Hamburg , 20246, Germany
Heidelberg , 69120, Germany
München , 81675, Germany
Tuebingen , 72076, Germany
Bergamo , 24127, Italy
Meldola , 47014, Italy
Milan , 20089, Italy
Nagoya-shi Aichi, 46786, Japan
Shibuya-ku Tokyo, 15089, Japan
Kamakura , 247-8, Japan
Kashiwa , 277-8, Japan
Kyoto , 602-8, Japan
Barcelona , 08916, Spain
Barcelona , 8035, Spain
Madrid , 28007, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Valencia , 46009, Spain
Valencia , 46017, Spain
Gothenborg , 413 4, Sweden
Lund , SE-22, Sweden
Stockholm , 141 8, Sweden
Uppsala , 75158, Sweden
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