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

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

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.

Sponsors & Collaborators

• MacroGenics

  lead INDUSTRY

Principal Investigators

• Ashley L. Ward, MD · MacroGenics

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-09

Primary Completion

2022-07-05

Completion

2022-07-05

FDA Drug

Yes

Countries

• United States
• France
• Germany
• Israel
• Italy
• Netherlands
• Spain
• United Kingdom

Study Locations