OncoMatch/Clinical Trials/NCT06756451
This Study is a FIH Study Which is Required to Understand the PK Characteristics, MTD, RP2D and Safety Profile.
Is NCT06756451 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including RJK-RT2831 dose-escalation phase Ia and RJK-RT2831 Dose Expansion Phase Ib for hematologic malignancies.
Treatment: RJK-RT2831 dose-escalation phase Ia · RJK-RT2831 Dose Expansion Phase Ib — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD123 positive (any level of positivity)
Required: CD33 positive (any level of positivity)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any prior anti-tumor therapy
must have received at least one previous treatment and have failed to current standard treatments that provide clinical benefit
Cannot have received: CD33-targeting agent (gemtuzumab ozogamicin)
Subjects with prior therapy using gemtuzumab ozogamicin or other CD33-targeting agents, or who have experience with CD33-targeting compounds in the clinical trial phase.
Cannot have received: CD123-targeting agent (tagraxofusp)
Subjects with prior therapy using tagraxofusp or other CD123-targeting agents, or who have experience with CD123-targeting compounds in the clinical trial phase.
Cannot have received: adoptive cell therapy (CAR-T cell therapy, autologous or donor natural killer cell or T lymphocyte infusions)
Exception: unless > 60 days prior to the first dose of study treatment and treatment-related toxicities have resolved to at least Grade 1
Received adoptive cell therapy, such as autologous or donor natural killer cell or T lymphocyte infusions (e.g., chimeric antigen receptor-T cells), unless > 60 days prior to the first dose of study treatment and treatment-related toxicities have resolved to at least Grade 1
Cannot have received: autologous haematopoietic stem cell transplant
Exception: within 12 weeks
Received an autologous haematopoietic stem cell transplant within 12 weeks.
Cannot have received: allogeneic organ transplantation
Subjects with a previous history of receiving allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation.
Cannot have received: allogeneic haematopoietic stem cell transplantation
Subjects with a previous history of receiving allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation.
Lab requirements
Blood counts
white blood cell count ≤ 30×10^9/L
Kidney function
creatinine clearance rate (CCr) > 50 mL/min calculated according to the Cockcroft-Gault method
Liver function
TBIL ≤ 1.5×ULN, TBIL ≤ 3×ULN if Gilbert's syndrome; ALT and AST ≤ 3 ×ULN
Cardiac function
mean QTcF > 480 ms in men/women; left ventricular ejection fraction < 50%; symptomatic or treatment-requiring abnormalities in rhythm, conduction, and resting ECG morphology; NYHA class III or IV heart failure; new onset angina or MI within 6 months; factors increasing risk of prolonged QTc; history of cerebral perfusion or stroke/TIA within 6 months
Substantial normal function of major organs with screening laboratory tests meeting the following criteria: Bone marrow function: white blood cell count ≤ 30×10^9/L; Liver function: TBIL ≤ 1.5×ULN, TBIL ≤ 3×ULN if Gilbert's syndrome; ALT and AST ≤ 3 ×ULN; Renal function: creatinine clearance rate (CCr) > 50 mL/min calculated according to the Cockcroft-Gault method; Coagulation function: activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤ 1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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