Safety Study of MGD006 in Relapsed / Refractory Acute Myeloid Leukemia (AML) or Intermediate-2 / High Risk MDS
- Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification
- Patients with AML must be unlikely to benefit from recommended standard of care defined by any one of the following criteria:
- leukemia refractory to ≥ 2 induction attempts (or ≥ 1 for patients > 65 years of age)
- leukemia in 1st relapse with initial CR duration < 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Life expectancy of at least 4 weeks
- Peripheral blast count </= 20,000/mm3 at the time of registration
- Acceptable laboratory parameters and adequate organ reserve
- Prior treatment with an anti-CD123-directed agent, with the exception of patients with relapsed disease after flotetuzumab treatment
- Need for concurrent other cytoreductive chemotherapy
- Any prior history of or suspected current autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and by laboratory testing)
- Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
- Antitumor therapy or investigational agent within 14 days or 5 half-lives of Cycle 1 Day 1
- Requirement, at the time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, nasal spray or ophthalmic solution
- Use of immunosuppressant medications in the 2 weeks of Cycle 1 Day 1
- Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks of Cycle 1 Day 1
- Known central nervous system (CNS) leukemia.
Open-label, multi-dose, single-arm, multi-center, Phase 1/2, dose-escalation study to define a maximum tolerated dose and schedule (MTDS), describe preliminarily safety, and to assess PK, immunogenicity, immunomodulatory activity, and potential anti-tumor activity of flotetuzumab in patients with AML whose disease is not expected to benefit from cytotoxic chemotherapy. This study is designed in three segments: the Single Patient Dose Escalation Segment, followed by the Multi-Patient Dose Escalation Segment and the MTDS Expansion Cohort Segment. The Multi-Patient Dose Escalation Segment will employ a classical 3+3 scheme to examine a series of increasing dose escalations in cohorts of patients with AML. Any Dose Escalation Cohort not exceeding the maximum tolerated dose may be expanded to include up to 15 patients for further evaluation of the safety, PK, and preliminary anti-tumor activity of flotetuzumab. Once the MTDS is established, the cohort of patients treated at that dose/schedule or a lower dose, will be expanded with the addition of up to 120 AML patients.
Trial Phase Phase I/II
Trial Type Treatment
- Primary ID CP-MGD006-01
- Secondary IDs NCI-2014-01526
- Clinicaltrials.gov ID NCT02152956