This is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 in combination with cytarabine in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.
This study will have two phases. Phase 1: the escalation phase is to establish the recommended phase 2 dose (RP2D) of HYML-122 given in combination with cytarabine.
Phase 2: the extension phase study will treat patients with FLT3 positive relapsed or refractory AML with HYML-122 in combination with cytarabine at the RP2D, and further evaluate efficacy and safety.
| Condition | Relapsed or Refractory Acute Myeloid Leukemia (AML) |
|---|---|
| Treatment | HYML-122; cytarabine |
| Clinical Study Identifier | NCT05241093 |
| Sponsor | Tarapeutics Science Inc. |
| Last Modified on | 27 January 2023 |
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