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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06756451 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CD33-targeting agent, CD123-targeting agent, adoptive cell therapy disqualifies patients from enrollment.
Does this trial require CD123?
Yes, CD123 positive is a required biomarker for enrollment.
Does this trial require CD33?
Yes, CD33 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 74 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify