OncoMatch/Clinical Trials/NCT05732103
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
Is NCT05732103 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies CTX-712 for acute myeloid leukemia.
Treatment: CTX-712 — The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or MDS/MPN (including CMML). The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development. This is followed by initial expansion cohorts in AML and/or HR-MDS where patients will be treated with CTX-712 at the RP2D to gain further confidence in the selected dose level. Additional expansion cohorts may be initiated if considered necessary. After RP2D is determined, Drug-Drug-Interaction cohorts will be started. The phase 2 part of the study will commence after the RP2D has been identified and confirmed and will evaluate therapeutic activity in R/R AML or R/R HR-MDS, in addition to confirmation of the safety profile.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: within 6 months of planned study treatment initiation and/or graft-versus host disease grade ≥ 1 following allogenic hematopoietic stem cell transplantation
History of allogenic hematopoietic stem cell transplantation within 6 months of planned study treatment initiation and/or graft-versus host disease grade ≥ 1 following allogenic hematopoietic stem cell transplantation
Cannot have received: chimeric antigen receptor T-cell therapy
History of or chimeric antigen receptor T-cell therapy or other modified T cell therapy
Cannot have received: allogeneic organ transplantation
Exception: excluding cornea
History of allogeneic organ transplantation (excluding cornea)
Lab requirements
Blood counts
White blood cell count at the time of the first dose <10 k/μL
Kidney function
Creatinine clearance (CL) ≥60 mL/min
Liver function
Total serum bilirubin < 1.5 × ULN; ALT/AST < 2.5 × ULN
Cardiac function
QTcF < 470 msec unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor; no NYHA Class III/IV heart failure; no known LVEF < 50%; no symptomatic arrhythmias not controlled by medications; no history of familial long QT syndrome; no myocardial infarction within six months prior to registration
Adequate organ function evidenced by the following laboratory values: Creatinine clearance (CL) ≥60 mL/min; Total serum bilirubin < 1.5 × ULN; ALT/AST < 2.5 × ULN; White blood cell count at the time of the first dose <10 k/μL. Cardiopulmonary abnormalities [excluded]: Myocardial infarction within six months prior to registration; NYHA Class III or IV heart failure or known LVEF < 50%; history of familial long QT syndrome; symptomatic arrhythmias not controlled by medications; QTcF ≥ 470 msec unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor; known moderate to severe and clinically significant chronic obstructive pulmonary disease, interstitial lung disease and/or pulmonary fibrosis (e.g., requiring home oxygen therapy).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Arizona · Phoenix, Arizona
- Mayo Clinic Florida · Jacksonville, Florida
- Northwestern University · Chicago, Illinois
- Mayo Clinic Comprehensive Cancer Center · Rochester, Minnesota
- The University of Rochester · Rochester, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05732103 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplantation, chimeric antigen receptor T-cell therapy, allogeneic organ transplantation disqualifies patients from enrollment.
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