First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult 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)
1/2期
提前终止
NCT05086315
| 适应症 | Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia |
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| 分期 | 1/2期 |
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| 申办方 | Sanofi |
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| 状态 | 提前终止 |
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| 受试者人数 | 101 人 |
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| 干预（药物） | SAR443579 |
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| 开始日期 | 2021年12月8日 |
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| 完成日期 | 2025年6月13日 |
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| 结果公布日 | 2026年7月6日 |
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摘要
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Cycle 1 Day 1 up to Cycle 1 Day 28. Each cycle duration in induction period was 28 days. · Participants
| Dose Escalation - Adult Arm: SAR443579 10-100 mcg/kg | 0 Participants |
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| Dose Escalation - Adult Arm: SAR443579 30-300 mcg/kg | 0 Participants |
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| Dose Escalation - Adult Arm: SAR443579 750 mcg/kg | 1 Participants |
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| Dose Escalation - Adult Arm: SAR443579 800 mcg/kg | 0 Participants |
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| Dose Escalation - Adult Arm: SAR443579 100-1000 mcg/kg | 0 Participants |
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| Dose Escalation - Adult Arm: SAR443579 300-1000 mcg/kg | 0 Participants |
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Dose Escalation (Cohort C): Number of Participants With Dose Limiting Toxicities
Cycle 1 Day 1 to Cycle 1 Day 28. Each cycle duration in induction period was 28 days.
Dose Expansion (Cohorts A1, A2 and D): Composite Complete Remission (CRc) Rate
Tumors were assessed on Day 28 of each induction cycle and Day 56 of each maintenance cycle until disease relapse, unacceptable AE, discontinuation, or death, whichever occurred first. Maximum treatment duration was 20.9 weeks. · percentage of participants
| Dose Expansion - Adult Arm (Cohort A1): SAR443579 1000 mcg/kg | 5.0 percentage of participants |
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