NL-OMON42264撤回不适用
A phase I, dose escalation study of S80880, a CD123 x CD3 *Dual Affinity Re-Targeting (DART)* bi-specific antibody-based molecule given as monotherapy in patients with acute leukaemias and other haematological malignancies expressing CD123 - CL1-80880-001
Institut de Recherches Internationales Servier I.R.I.S0 个研究点目标入组 8 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 8
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
- •- male or female > or <= 18 years
- •- Patients with cytologically confirmed and documented primary or secondary acute myeloid leukaemia (AML) without established therapeutic alternatives or when established therapeutic alternatives are ineffective, poorly tolerated or unacceptable for the patient:
- •- In newly diagnosed patients * 70 years not eligible for cytotoxic chemotherapy or
- •- in patients with relapsed or refractory disease who have failed conventional therapy after at
- •least 1 line of treatment and who are not eligible for salvage therapy;
- •In following patients, in case established therapeutic alternatives are not available or when established therapeutic alternatives are ineffective, poorly tolerated or unacceptable for the patient:
- •- cytologically confirmed and documented relapsed/refractory B-cell acute lymphoid leukaemia (B-ALL),
- •- cytologically confirmed and documented relapsed/refractory Acute Leukaemia of Ambiguous Lineage (ALAL)
- •- patients with intermediate -2 of high risk myelodysplastic syndrome (MDS)
- •- cytologically and histologically confirmed relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN);- Circulating white blood cells * 20 000/mm3,
- •- Adequate hepatic and renal function
- •- life expectancy > or <= 4 weeks
- •- ECOG (Eastern Cooperative Oncology Group) performance status < or <= 2
排除标准
- •Diagnosis of myeloid sarcoma,
- •History of other malignancy within 3 years prior to start of protocol-specified therapy (exceptions: see protocol)
- •Patients who have not recovered from toxicity of previous antileukaemic therapy, including grade * 2 non-haematologic toxicity, prior to starting the test drug,
- •Patients previously treated by anti-CD123 therapy,
- •Any previous anticancer treatment for leukaemic disease within at least 2 weeks,
- •Previous radiotherapy or immunotherapy in the 4 weeks prior to first IMP intake,
- •Patients with previous history of allogeneic stem cell transplantation;
- •Any prior history of or suspected current autoimmune disorders (exceptions: see protocol),
- •Severe uncontrolled fungal, bacterial or viral infection,
- •Leukaemic central nervous system involvement,
- •Pregnant or breastfeeding women,
- •known hypersensitivity to murine or recombinant proteins, polysorbate 80, recombinant human serum albumin, benzyl alcohol or any excipient contained in the S80880 drug formulation, history of Quincke oedema,
- •Known infection with human immunodeficiency virus (HIV), infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive),
- •Any other diseases (e.g. adrenal insufficiency, malabsorption syndromes, metabolic dysfunction, physical examination finding), or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for test drug complications.
研究者
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