*CA059-001: Phase 1 of CC-95251 Alone/Combo in Subjects with ACL or MDS
Research type
Research Study
Full title
A Phase 1, Open-Label, Dose Finding Study of CC-95251 Alone and in Combination with Antineoplastic Agents in Subjects with Acute Myeloid Leukemia and Myelodysplastic Syndromes
IRAS ID
1004561
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2021-002799-38
Clinicaltrials.gov Identifier
Research summary
This is a multicentre, phase 1 study of the investigational drug CC-95251 alone and in combination with azacitidine in patients ≥18 years with acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). CC-95251 is an antibody designed to target cancer cells for removal from the body. It is given as an infusion into a vein and may require hospitalisation for at least 24 hours. Azacitidine is approved in Europe for the treatment of AML and MDS. It changes how diseased cells in the blood and bone marrow grow and multiply. 166 patients will take part in this study, 16 in the UK. Patients and Doctors will know what treatment they are on.
The study has 3 parts(A-C): Parts A&B include patients with relapsed/refractory AML and MDS. Part A will test the safety of increasing amounts of CC-95251 alone and combined with azacitidine to find out what dose can be taken without serious side effects. Part B will test CC-95251 alone and in combination with azacitidine in a larger number of people, to further evaluate the safety and see if it is effective. Part C will give previously untreated MDS patients CC-95251 in combination with standard of care azacitidine.
During the study, patients will have the following procedures: physical exams, heart scans (MUGA /ECHO), ECG, vital signs (blood pressure, heart rate and temperature), blood & urine sampling and pregnancy testing. Patients will receive study drug for max. 2 years, until they withdraw their consent, no longer tolerate the study drug, or their disease worsens. Patients will have follow-up until about 56 days from last dose. Long-term follow-up will be every 8 weeks for the 1st year then every 12 weeks (in clinic/by phone) for up to 2 years or until death, lost to follow-up, or end of trial.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0286
Date of REC Opinion
24 Feb 2022
REC opinion
Further Information Favourable Opinion