NL-OMON54392招募中不适用
A Phase 1 Study of SEA-CD70 in Myeloid Malignancies - SGNS70-101
Seagen Inc0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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 64（—）
入选标准
- •SEA-CD70 dose-escalation cohort in relapsed/refractory (HMA-failure) MDS, Part
- •1. Subjects with cytologically/histologically confirmed MDS according to the
- •2016 World Health Organization (WHO) classification with the following:
- •* Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria as
- •defined either:
- •* 5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood
- •(MDS-EB-1), or
- •* 10%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood
- •(MDS-EB-2)
- •* MDS that is relapsed or refractory and must not have other therapeutic
- •options known to provide clinical benefit in MDS available.
- •* Treatment failure after prior HMA therapy for MDS, defined as one of the
- •* Progression (per 2006 IWG criteria) at any time after initiation of HMA
- •* Lack of response (failure to achieve CR, PR, or hematologic improvement [HI]
- •per 2006 IWG criteria) after at least 6 cycles of azacitidine (or equivalent
- •oral HMA) or 4 cycles of decitabine (or equivalent oral HMA).
- •* Relapse after achievement of CR, PR, or HI (per 2006 IWG criteria).
- •* Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to
- •treatment discontinuation).
- •* Subjects with isolated 5q-/5q- syndrome must have progressed, failed,
- •relapsed, or not tolerated lenalidomide in addition to HMA.
- •2. Must be off all treatments for MDS (including HMAs) for >=4 weeks; growth
- •factors (e.g., G-CSF, erythropoietin and thrombopoietin) and transfusions are
- •allowed before and during the study as clinically indicated.
- •3. Age >=18 years.
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1
- •SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS, Part B:
- •5. Subjects with cytologically/histologically confirmed MDS according to the
- •2016 WHO classification with the following:
- •* Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria as
- •defined either:
- •* 5%-9% blasts in the bone marrow or 2%-4% blasts in the peripheral blood
- •(MDS-EB-1), or
- •* 10%-19% blasts in the bone marrow or 5%-19% blasts in the peripheral blood
- •(MDS-EB-2)
- •* MDS that is relapsed or refractory and must not have other therapeutic
- •options known to provide clinical benefit in MDS available.
- •* Treatment failure after prior HMA therapy for MDS defined as one of the
- •* Progression (per 2006 IWG criteria) at any time after initiation of HMA
- •* Lack of response (failure to achieve CR, PR, or HI per 2006 IWG criteria)
- •after at least 6 cycles of azacitidine (or equivalent oral HMA) or 4 cycles of
- •decitabine (or equivalent oral HMA).
- •* Relapse after achievement of CR, PR, or HI (per 2006 IWG criteria).
- •* Intolerance of HMA (Grade 3 or higher non-hematologic toxicity leading to
- •treatment discontinuation).
- •* Subjects with isolated 5q-/5q- syndrome must have progressed, failed,
- •relapsed, or not tolerated lenalidomide in addition to HMA.
- •6. Must be off all treatments for MDS (including HMAs) for >=4 weeks; growth
- •factors (e.g., G-CSF, erythropoietin and thrombopoietin) and transfusions are
- •allowed before and during the study as clinically indicated.
- 另有 5 项未显示
排除标准
- •1. History of another malignancy within 3 years before the first dose of study
- •drug or any evidence of residual disease from a previously diagnosed
- •malignancy. Exceptions are malignancies with a negligible risk of metastasis or
- •death (e.g., 5-year OS >=90%), such as adequately treated carcinoma in situ of
- •the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal
- •carcinoma in situ, or Stage I uterine cancer.
- •2. Previous exposure to CD70-targeted agents.
- •3. Prior allogeneic hematopoietic stem cell transplant, for any condition.
- •4. Central nervous system leukemia based on imaging or documented positive
- •cytology in cerebral spinal fluid.
- •5. Any uncontrolled Grade 3 or higher (per the National Cancer Institute*s
- •Common Terminology Criteria for Adverse Events [NCI CTCAE], version 5.0) viral,
- •bacterial, or fungal infection within 14 days prior to the first dose of study
- •treatment. Antimicrobial prophylaxis or ongoing treatment of
- •resolving/controlled infection is permitted.
- •6. Subjects who have experienced major surgery (defined as requiring general
- •anesthesia and hospitalization for >24 hours) or significant traumatic injury
- •that would place the subject at undue risk from study procedures, in the
- •opinion of the investigator, within 14 days before the first dose of study
- •treatment. Subjects must have recovered adequately from the surgery/injury, or
- •complications thereof, prior to starting treatment.
- •7. Positive for hepatitis B by surface antigen expression. Active hepatitis C
- •infection (positive by PCR or on antiviral therapy for hepatitis C within the
- •last 6 months). Subjects who have been treated for hepatitis C infection are
- •permitted if they have documented sustained virologic response of 12 weeks.
- •8. Known to be positive for human immunodeficiency virus (HIV).
- •9. Known active or latent tuberculosis.
- •10. History of clinically significant sickle cell anemia, autoimmune hemolytic
- •anemia, or idiopathic thrombocytopenic purpura.
- •11. History of clinically significant chronic liver disease (e.g., liver
- •cirrhosis) and/or ongoing alcohol abuse.
- •12. Documented history of a cerebral vascular event (stroke or transient
- •ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms
- •consistent with New York Heart Association Class III-IV (Appendix F) within 6
- •months prior to their first dose of SEA-CD70.
- •13. chemotherapy, systemic radiotherapy, biologics, other anti-neoplastic or
- •investigational agents, and/or other antitumor treatment with immunotherapy
- •that is not completed 4 weeks prior to first dose of SEA-CD70. Focal
- •radiotherapy that is not completed 2 weeks prior to the first dose of SEA-CD70.
- •Hydroxyurea or 6-mercaptopurine used for cytoreduction may be given up to 24
- •hours prior to treatment.
- •14. Subjects with either of the following:
- •a. A condition requiring systemic treatment with either corticosteroids (>10 mg
- •daily prednisone or equivalent) or other immunosuppressive medications within 2
- •weeks of first dose of SEA-CD70 (inhaled, topical, intraocular, intranasal, and
- •intraarticular steroids are permitted in the absence of active immune disease,
- •and steroid premedication for prevention of hypersensitivity reactions to
- •radiographic contrast is permitted).
- •b. Active known or suspected clinically significant autoimmune disease or
研究者
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