Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Sandy Wong
Headshot of Sandy Wong
Sandy Wong

Description

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.

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

Details

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 2 years or extended up to 5 years for subjects maintaining clinical benefit at the discretion of the Safety Review Committee, until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

Keywords

Multiple Myeloma, BCMA X CD3 T Cell, Antibody, CC-93269, Relapsed and Refractory, Neoplasms, Plasma Cell, Administration of CC-93269

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University Of California San Francisco Medical Center
    San Francisco California 94142 United States
  • Swedish Cancer Institute
    Seattle Washington 98104 United States

Lead Scientist at UCSF

  • Sandy Wong
    Assistant Professor, Medicine, School of Medicine. Authored (or co-authored) 88 research publications. Research interests: amyloidosis · plasma cell dyscrasias · multiple myeloma · MGUS · SMM

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT03486067
Phase
Phase 1 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 220 study participants
Last Updated