EUCTR2015-003813-11-GB进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •2. = 2 but = 4 cycles of gemtuzumab ozogamicin monotherapy
- •b. Early relapse (ER) AML, defined as AML in first relapse with initial CR1 duration < 6 months
- •3. Limit of 3 prior lines of therapy: up to 2 induction (induction, reinduction) 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 < or = 2.
- •5. Life expectancy of at least 4 weeks.
- •6. Peripheral blast count < or = 20,000/mm3 at the time of registration (see related Exclusion Criterion 3).
- •7. Acceptable laboratory parameters and adequate organ reserve
- •8. Adult: Eighteen (18) years of age or older
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •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 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, 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 Day 1).
- •10. Known central nervous system (CNS) leukemia.
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