NCT02152956

Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment. Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a the assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.

Conditions

• AML

Interventions

Type	Name	Description
BIOLOGICAL	Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
BIOLOGICAL	Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
BIOLOGICAL	Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
BIOLOGICAL	Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
BIOLOGICAL	Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
BIOLOGICAL	Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
BIOLOGICAL	Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
BIOLOGICAL	Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
BIOLOGICAL	Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.
DRUG	Ruxolitinib	Oral inhibitor of JAK kinase
BIOLOGICAL	Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose	Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART molecule.

Timeline

• Start date: 2014-06-09
• Primary completion: 2022-07-05
• Completion: 2022-07-05
• First posted: 2014-06-02
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

43 sites across 8 countries: United States, France, Germany, Israel, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study