Phase1/2 study of MGD006 in patients with AML or MDS V8

• Research type

  Research Study

• Full title

  A Phase 1/2, First-in-Human, Dose Escalation study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome

• IRAS ID

  246173

• Contact name

  Jan Davidson-Moncada

• Contact email

  Davidsonj@macrogenics.com

• Sponsor organisation

  Macrogenics Inc

• Eudract number

  2015-003813-11

• Clinicaltrials.gov Identifier

  NCT02152956

• Clinicaltrials.gov Identifier

  116832, IND Number

• Duration of Study in the UK

  1 years, 8 months, 31 days

• Research summary

  This is a Phase 1/2, open label, dose-escalation and cohort expansion study in patients with AML, a blood and bone marrow cancer. Patients from Europe and the US are participating in this study.
  The study consists of 2 phases, a Dose Escalation followed by a Cohort Expansion. The Dose Escalation part is complete, where 47 participants received the study drug. Patients are now being enrolled in the Cohort Expansion part.
  MGD006 is being co-developed by MacroGenics, Inc. and Servier.. MGD006 is a type of antibody made to attach to both the cancerous B-cells and to T-cells, causing the T-cells to destroy the malignant cells.
  The purpose of the study is to provide answers to the following questions: what side effects are caused by MGD006; what is the highest dose of MGD006 that can be given safely; how long does MGD006 stay in the blood; how long does it take MGD006 to leave the body and whether MGD006 is a possible treatment for AML.
  The duration of each treatment cycle is 4 weeks. During Cycle 1, patients receive MGD006 as 24-hour continuous infusion. For each additional cycle of treatment, dosing continues on 4 days/week of continuous infusion.
  During the first week of Cycle 1 MGD006 will is given in multiple doses, each dose slightly higher than the last. Dosing starts at 30 (day 1), then 60 (day 2), 100 (day 3), 200 (day 4), 300 (day 5), 400 (day 6) and 500 ng/kg/day (day 7). The dose of 500 ng/kg/day is given 7-days continuously for Weeks 2, 3 and 4 of Cycle 1. MGD006 is then given at 500 ng/kg/day on a 4 days on/3 days off schedule for all subsequent cycles.
  Blood results, bone marrow assessments and physical well-being are periodically checked to measure how effective and safe MGD006 is.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  19/LO/0375

• Date of REC Opinion

  12 Jul 2019

• REC opinion

  Further Information Favourable Opinion