CA091-P01 (CC-91633-AML-001) - Ph I CC-91633 FIH in AML and MDS Mono

• Research type

  Research Study

• Full title

  A Phase 1, open-label, dose-finding Study of CC-91633 (BMS-986397) in Subjects with Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory higher-risk Myelodysplastic syndrome

• IRAS ID

  1008765

• Contact name

  GSM-CT Representative

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Celgene Corp.

• Eudract number

  2020-005329-95

• Clinicaltrials.gov Identifier

  NCT04951778

• Research summary

  This Phase 1 study is assessing if the novel compound CC-91633 can help people with Relapsed or Refractory Acute Myeloid Leukaemia (R/R AML) or Relapsed or Refractory Higher-Risk Myelodysplastic syndrome (R/R-HR MDS). Relapsed or refractory means that the disease has come back after treatment or is no longer responding to available therapies.
  It is the first study testing CC-91633 in humans. Part A is testing increasing amounts of CC-91633 to find out which dose can be tolerated without serious side effects. Part B will evaluate the highest or near highest safe dose. In the UK, only Part B of the study will be implemented, including about 15 patients out of a total of 80 patients globally. About 120 patients will take part in Part A and B of this study globally.
  R/R AML and R/R-HR MDS patients ≥ 18 years will be invited. All participants will receive CC-91633. There is no placebo or randomisation.
  There are three phases to the study: During Screening (max. 28 Days), initial tests check whether patients are able to take part. Throughout the treatment period, patients will receive CC-91633 as capsules taken by mouth. The dosing schedule will be once daily up to 14 days or twice a week for up to 4 weeks every 28-day cycle for 6 cycles. The capsules will be taken in the hospital or at home. This period might be extended to up to 2 years for patients if it is safe to continue and they are benefitting from it. The follow-up period will assess patients’ safety after the last CC-91633 dose and will continue for at least 28 days. All patients will be followed for up to 2 years. During this time, patients will no longer receive the study treatment, but will still be in contact with the study team to monitor their health.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  24/SC/0056

• Date of REC Opinion

  17 Apr 2024

• REC opinion

  Further Information Favourable Opinion