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 (May 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
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic organ transplantation
Exception: excluding cornea
History of allogeneic organ transplantation (excluding cornea)
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: CAR-T cell therapy or other modified T cell therapy
History of or chimeric antigen receptor T-cell therapy or other modified T cell therapy
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
No myocardial infarction within six months prior to registration; NYHA Class III or IV heart failure or known LVEF < 50%; no history of familial long QT syndrome; no symptomatic atrial or ventricular 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
Adequate organ function evidenced by the following laboratory values: Creatinine clearance (CL) ≥60 mL/min Total serum bilirubin < 1.5 × ULN Alanine aminotransferase (ALT) Aspartate aminotransferase(AST) < 2.5 × ULN White blood cell count at the time of the first dose <10 k/μL. Cardiopulmonary abnormalities: see exclusion criteria.
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
- Mayo Clinic Comprehensive Cancer Center · Rochester, Minnesota
- The University of Rochester · Rochester, New York
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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