NL-OMON55908招募中2 期
An open-label, first-in-human, dose-escalation/expansion study of SAR443579 administered as single agent by intravenous infusion in adult and pediatric participants with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), high risk-myelodysplasia (HR-MDS) or blastic plasmacytoid dendritic cell neoplasm (BPDCN) - TCD17197
Sanofi BV0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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
- 0 至 99（—）
入选标准
- •- Participant must be >=1 year old at the time the trial participant or legal
- •guardian signs the informed consent form and will be assigned as follows:
- •Adult arm: aged >=12 years old.
- •Pediatric arm: aged 1 to 17 years old.
- •For participants of the Escalation Part only:
- •- Adult and Pediatric Arms: Confirmed diagnosis of primary or secondary AML
- •[any subtype except acute promyelocytic leukemia (APL) and juvenile
- •myelomonocytic leukemia (JMML)] according to World Health Organization (WHO)
- •classification. Patients with AML must meet one of the following criteria, a),
- •b) c) or d) and are limited to those with no available (or are ineligible)
- •therapy with known clinical benefit.
- •a) Primary Induction Failure (PIF) AML
- •b) Early relapse (ER) AML
- •c) Leukemia in first or higher relapse
- •d) For participants aged 1 to 17 years old, primary induction failure is
- •defined as disease refractory after two cycles of induction therapy according
- •to Children*s Oncology Group (COG) protocol guidelines (40).
- •- Adult arm only: Confirmed diagnosis of cluster of differentiation 123 (CD123)
- •-- Not eligible for induction therapy and having completed >=2 cycles of any of
- •the following: hypomethylating agent (eg, 5 azacitidine or decitabine) and/or
- •venetoclax, chemotherapy, or targeted agents.
- •-- Not eligible for autologous stem cell transplant (ASCT) and having completed
- •>=1 course of induction therapy.
- •- Adult and Pediatric arms and escalation part only: Confirmed diagnosis of
- •CD123+ B-ALL without extramedullary lesions that have no available (or are
- •ineligible) therapy with known clinical benefit. Participants with non-CNS
- •chloromatous disease are not allowed in the study.
- •For Participants in the Expansion Part Only (adults only):
- •- For participants in Cohort A: Participants meeting inclusion criteria for AML
- •patients that have been primary refractory (PIF) to prior induction treatment
- •or who have had ER occurring 6 months or less after an initial remission on
- •prior induction treatment.
- •- For participants in Cohort B: Participants meeting inclusion criteria for AML
- •patients that have had late relapse (LR), occurring more than 6 months after an
- •initial remission on prior induction treatment.
- •- Pediatric arm and escalation part only: Confirmed diagnosis of BPDCN
- •according to World Health Organization (WHO) 2022 classification (39), who have
- •relapsed or refractory disease with no available (or are ineligible) therapy
- •with known clinical benefit.
- •- Pediatric arm and expansion part only: For participants in Cohort C:
- •Participants with AML who have relapsed according to I 02 or have recurrent
- •disease resistant or intolerant to available therapies.
排除标准
- •-Eastern Cooperative Oncology Group (ECOG) performance status >2 (>=18
- •years-old). Karnovsky Scale (16-17 years-old) <50% or Lansky Scale (<16
- •years-old) <50%.
- •- Ongoing or recent (within 5 years) evidence of significant autoimmune disease
- •that requires or required treatment with systemic immunosuppressive treatments,
- •which may suggest a risk for immune related adverse events. The following are
- •not exclusionary: vitiligo, childhood asthma that has resolved, residual
- •hypothyroidism that required only hormone replacement or psoriasis that does
- •not require systemic treatment.
- •- History of an invasive malignancy that requires active therapy (adjuvant
- •hormonal therapy is allowed) other than the one treated in this study, with the
- •exception of resected/ablated basal or squamouscell carcinoma of the skin or
- •carcinoma in situ of the cervix, or other local tumors considered cured by
- •local treatment)
- •- Evidence of active central nervous system leukemia at the time of enrollment
- •as evidenced by cytology or pathology. Except for participants aged 1 to 17
- •years, central nervous system 1 disease (CNS1) and CNS2 disease according to
- •COG classification (41) are
- •-Known acquired immunodeficiency syndrome (AIDS-related illnesses) or HIV
- •disease requiring antiretroviral treatment, or having active hepatitis B or C
- •infection, or SARS-CoV-2 infection.
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