NL-OMON55771已完成不适用
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 - CP-MGD006-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients must have a confirmed diagnosis of primary or secondary AML (any
- •subtype except acute promyelocytic leukemia [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:
- •- An intensive induction attempt, per institution. Induction attempts include
- •high dose and/or standard-dose cytarabine +/- an anthracyclines/anthracenedione
- •+/- and anti-metabolite, with or without growth factor or targeted therapy
- •containing regimes.
- •Examples include but are not limited to:
- •1. One cycle of high dose cytarabine (HiDAC) containing
- •2. One cycle of liposomal cytarabine and daunorubicin
- •3. Two cycles of standard dose cytarabine containing regimen
- •- For adults who are age 75 years or older, who have comorbidities that
- •preclude use of intensive induction chemotherapy; PIF is defined as AML
- •refractory to one of the following less intensive regimes, 1 or 2:
- •1. >= 2 but <= 4 cycles of Bcl-2 inhibitors in combination with
- •azacitidine, decitabine, or low dose cytarabine
- •2. >= 2 but <= 4 cycles of gemtuzumab ozogamicin monotherapy
- •b. Early Relapse (ER) AML, defined as AML in first relapse with initial CR 1
- •duration < 6 months.
- •3. Limit of 3 prior lines of therapy (excluding focal radiation therapy for
- •palliative purposes): up to 2 induction (induction, re-induction) or 1
- •induction plus/minus 1 consolidation attempt, followed by a maximum of 1
- •salvage/re-induction attempt.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status less-than or
- •equal to 2.
- •5. Life expectancy of at least 4 weeks.
- •6. Peripheral blast count less-than or equal to 20,000/mm3 at the time of
- •first dose of study treatment (see related Exclusion Criterion 3).
- •7. Acceptable laboratory parameters and adequate organ reserve.
- •8. Adult: Eighteen (18) years of age or older.
排除标准
- •1. Prior history of allogeneic stem cell transplantation
- •2. Prior treatment with an anti-CD123-directed agent.
- •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 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 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
- •10. Known central nervous system (CNS) leukemia.
研究者
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