Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma
Leukemia
Multiple Myeloma
Plasma cell neoplasm
18 Years and older, Male and Female
CC-93269-MM-001 (primary)
NCI-2018-02280
2017-003448-19
U1111-1210-6325
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.
Objectives
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
- 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
Treatment Sites in Georgia
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