Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

Active:	Yes
Cancer Type:	Leukemia Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT03486067
Trial Phases:	Phase I	Protocol IDs:	CC-93269-MM-001 (primary) NCI-2018-02280 2017-003448-19 U1111-1210-6325
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Celgene
NCI Full Details:	http://clinicaltrials.gov/show/NCT03486067

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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