a study of hyml-122 and cytarabine in patients with flt3 positive relapsed or refractory acute myeloid leukemia (aml)

Conditions: Relapsed or Refractory Acute Myeloid Leukemia (AML)

Summary: 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.

Eligibility criteria:
inclusion criteria: * fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol. * males and/or females at least 18 years old when signing the informed consent form. * histologically confirmed aml (defined using who criteria 2016) with one of the following: refractory to at least 1 cycle of induction chemotherapy. relapsed after achieving remission with a prior therapy. * subject is positive for flt3 mutation in bone marrow or blood after completion of the subject's last interventional treatment. * eastern cooperative oncology group performance status (ecog) ≤2 at screening. * life expectancy of at least 3 months. * women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose. exclusion criteria: * known or suspected allergies to any of the investigational drug composition (hyml-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol). * medical history and surgical history excluded according to the protocol. * any previous medical treatment history exclude from the protocol. * abnormal laboratory results exclude from the protocol. * combination of treatments and/or drugs required during the study period and cannot be discontinued that excluded from the protocol. * alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g/d for men, ≥20g/d for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g/d. alcohol volume (g) conversion formula=alcohol consumption (ml)\*alcohol content (%)\*0.8. * abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose. * history of drug abuse or drug addicts. * subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.