the Image

Clinical Trial Details

If you are a patient or a caregiver and would like to learn more our cancer clinical trials call toll-free 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials) or email cancerclinicaltrials@bsd.uchicago.edu .

Share this:
Brief Title A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Official Title A Phase 1, Open-label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Acute Myeloid Leukemia and High-Risk Myelodsplastic Syndrome
Principal Investigator Stock, Wendy
Brief Summary Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion in Part B. The primary objective is to determine the safety and tolerability of CC-90002 and also to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-90002.
Gender Both
Ages 18 Years
Enrollment 78
Accepts Healthy Volunteers No
Lead Sponsor Celgene CorporationIndustry
Collaborator
Study Design Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Leukemia, Myeloid, Acute
Detail for Health Professional (on clinicaltrials.gov)
More clinical trials by this PI