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

MacroGenics, Inc.0 sites330 target enrollmentDecember 29, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome
Sponsor: MacroGenics, Inc.
Enrollment: 330
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

December 29, 2015

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Patients must have a confirmed diagnosis of primary or secondary AML (any subtype except APL) according to World Health Organization (WHO) classification.
•2\. Patients with AML must meet one of the following criteria:
•a. Primary Induction Failure (PIF) AML, defined as disease refractory to one of the following, i or ii:
•i. An intensive induction attempt, per institution. Induction attempts include high\-dose and/or standard\-dose cytarabine ± an anthracyclines/anthracenedione ± an anti\-metabolite, with or without growth factor or targeted therapy containing regimens.
•Examples include but are not limited to:
•1\. One cycle of high dose cytarabine (HiDAC) containing regimen
•2\. One cycle of liposomal cytarabine and daunorubicin
•3\. Two cycles of standard dose cytarabine containing regimen
•ii. For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens, 1 or 2:
•1\. \= 2 but \= 4 cycles of Bcl\-2 inhibitors in combination with azacitidine, decitabine, or low dose cytarabine

•1\. Prior history of allogeneic stem cell transplantation
•2\. Prior treatment with an anti\-CD123\-directed agent, with the exclusion of patients with relapsed disease after MGD006 treatment.
•3\. Need for concurrent other cytoreductive chemotherapy
•4\. Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation)
•5\. Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
•6\. Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, moleculartargeted therapy, retinoid therapy, or investigational agent) within 14 days or 5 half\-lives of Cycle 1 Day 1\.
•7\. Requirement, at the time of study entry, for concurrent steroids \> 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, otic preparations, nasal spray or ophthalmic solution.
•8\. Use of immunosuppressant medications (other than steroids as noted) in the 2 weeks prior to study drug administration (Cycle 1 Day 1\).
•9\. Use of granulocyte colony stimulating or granulocyte\-macrophage colony stimulating factor in the 2 weeks prior to study drug administration (Cycle 1 Day 1\).
•10\. Known central nervous system (CNS) leukemia.