This Study is a FIH Study Which is Required to Understand the PK Characteristics, MTD, RP2
This study is a first-in-human (FIH) study which is required to understand the safety, tolerability, pharmacokinetics and preliminary efficacy of RJK-RT2831 injection in patients with hematologic malignancies
| Condition(s) | Hematologic Malignancies |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This study is a first-in-human (FIH) study which is required to understand the safety, tolerability, pharmacokinetics and preliminary efficacy of RJK-RT2831 injection in patients with hematologic malignancies |
| Who can participate | Inclusion Criteria: * 1\. A male or female aged ≥ 18 and \<75 years old. * 2\. The following three points are evaluated by the investigator and are deemed suitable to participate in the study: a) The subject fully understands the requirements of this study and voluntarily signs a written informed consent form; b) Be able to comply with the medication requirements of this study as well as all study related procedures and assessments; c) Not deemed as potentially unreliable and/or uncooperative. * 3\. An ECOG physical status score is ≤ 2 and an expected survival is ≥ 3 months. * 4\. Relapsed or refractory acute myeloid leukemia (AML) that meets the following criteria will be included in Phase Ⅰa : Patients diagnosed with AML according to the 5th edition of the World Health Organization (WHO) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Lead sponsor | Nanjing RegeneCore Biotech Co., Ltd. |
| Locations | Hefei, Anhui, China; Hefei, Anhui, China; Guangzhou, Guangdong, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Guilin, Guangxi, China (+10 more sites) |
| Start date | 2025-03-25 |
| NCT ID | NCT06756451 |
| Official listing | https://clinicaltrials.gov/study/NCT06756451 |