Actively Recruiting
This Study is a FIH Study Which is Required to Understand the PK Characteristics, MTD, RP2D and Safety Profile.
Led by Nanjing RegeneCore Biotech Co., Ltd. · Updated on 2026-01-30
71
Participants Needed
16
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
This Study is a FIH Study Which is Required to Understand the PK Characteristics, MTD, RP2D and Safety Profile.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A male or female aged 63 18 and <75 years old.
- Fully understands the study requirements and voluntarily signs informed consent.
- Able to comply with study treatment and all related procedures and assessments.
- ECOG physical status score 64 2 and expected survival of at least 3 months.
- For Phase Ia: Diagnosed with relapsed or refractory acute myeloid leukemia (excluding acute promyelocytic leukemia) having failed at least one prior treatment.
- For Phase Ib: Diagnosed with relapsed or refractory AML or high-risk/very-high-risk myelodysplastic syndromes as defined by specified classifications.
- Positive test for CD33 and/or CD123 markers.
- Consent to bone marrow biopsy/aspiration and to medical device implantation for intravenous drug administration.
- Recovery from prior treatment toxicities to Grade 1 or less (except certain exceptions).
- Normal major organ function based on screening laboratory tests including blood, liver, kidney, and coagulation parameters.
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception during study and for 3 months after last dose.
You will not qualify if you...
- Suspected or confirmed acute promyelocytic leukemia or other specified hematological tumors.
- Received anticancer therapy or investigational drugs within specified timeframes prior to first dose.
- Cardiovascular disease including prolonged QTc, low heart function, arrhythmias, recent heart attack, or stroke.
- Evidence of active infectious diseases such as hepatitis B or C, HIV, syphilis, or tuberculosis.
- Leukemic extramedullary infiltration.
- Long-term steroid therapy exceeding 10 mg prednisone daily except for specific conditions.
- Autoimmune blood disorders requiring active intervention.
- Recent major surgery or unhealed wounds within 4 weeks prior to treatment.
- Uncontrolled co-morbidities including severe infection, other malignancies within 5 years, cancerous meningitis, uncontrolled hypertension, or other serious illnesses.
- Expected to receive other anti-tumor therapy during the study (except palliative radiotherapy).
- Prior therapy with CD33 or CD123 targeting agents.
- Allergy to components of RJK-RT2831 formulation.
- Pregnant or breastfeeding women.
- Participation in another interventional clinical study or recent investigational drug use.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Other factors deemed by the investigator to interfere with study participation or results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
The First Affiliated Hospital of USTC
Hefei, Anhui, China, 230001
Actively Recruiting
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
4
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Actively Recruiting
5
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
6
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
Actively Recruiting
7
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
8
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 071000
Actively Recruiting
9
Tangshan Central Hospital
Tangshan, Hebei, China, 063008
Actively Recruiting
10
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
11
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
12
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
13
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
14
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
15
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
16
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
G
Guo Qian
CONTACT
W
Wang J xiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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