Spots Global Cancer Trial Database for Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
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Trial Identification
Brief Title: Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
Official Title: 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
Study ID: NCT03486067
Conditions
Interventions
Study Description
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 105, Birmingham, Alabama, United States
Local Institution - 103, San Francisco, California, United States
Local Institution - 107, New Haven, Connecticut, United States
Local Institution - 106, Atlanta, Georgia, United States
Local Institution - 109, Boston, Massachusetts, United States
Local Institution - 111, Boston, Massachusetts, United States
Henry Ford Medical Center - New Center One, Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai Mount Sinai West, New York, New York, United States
Local Institution - 101, Seattle, Washington, United States
Local Institution - 305, Erlangen, , Germany
Local Institution - 303, Hamburg, , Germany
Local Institution - 302, Heidelberg, , Germany
Local Institution - 306, München, , Germany
Local Institution - 304, Tuebingen, , Germany
Local Institution - 402, Bergamo, , Italy
Local Institution - 403, Meldola, , Italy
Local Institution - 401, Milan, , Italy
Local Institution - 602, Nagoya-shi, Aichi, Japan
Local Institution - 603, Shibuya-ku, Tokyo, Japan
Local Institution - 605, Kamakura, , Japan
Local Institution - 604, Kashiwa, , Japan
Local Institution - 601, Kyoto, , Japan
Local Institution - 206, Barcelona, , Spain
Local Institution - 208, Barcelona, , Spain
Local Institution - 205, Madrid, , Spain
Local Institution - 201, Pamplona, , Spain
Local Institution - 203, Salamanca, , Spain
Local Institution - 204, Santander, , Spain
Local Institution - 207, Valencia, , Spain
Local Institution - 202, Valencia, , Spain
Local Institution - 504, Gothenborg, , Sweden
Local Institution - 502, Lund, , Sweden
Local Institution - 501, Stockholm, , Sweden
Local Institution - 505, Uppsala, , Sweden
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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