Actively Recruiting
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
Led by Chordia Therapeutics, Inc. · Updated on 2026-04-13
225
Participants Needed
8
Research Sites
301 weeks
Total Duration
On this page
Sponsors
C
Chordia Therapeutics, Inc.
Lead Sponsor
T
Theradex
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with AML, HR-MDS, or high marrow blast MDS/MPN including CMML (only AML and HR-MDS eligible in expansion cohorts)
- Have received 1 to 4 prior lines of therapy (1 to 3 prior lines allowed in expansion cohorts)
- Adequate organ function with creatinine clearance ≥60 mL/min, total serum bilirubin <1.5 times upper limit of normal, ALT and AST <2.5 times upper limit of normal, and white blood cell count <10,000/µL at first dose
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before treatment and agree to use highly effective contraception during treatment and for 4 months after last dose
- Male participants with female partners of childbearing potential must agree to use effective barrier contraception or abstain during treatment and for 4 months after last dose
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Isolated extramedullary relapse (phase 2 only)
- Active central nervous system leukemia
- History of other malignancies
- Recent myocardial infarction within 6 months
- New York Heart Association Class III or IV heart failure or left ventricular ejection fraction below 50%
- History of familial long QT syndrome
- Uncontrolled symptomatic atrial or ventricular arrhythmias
- QTcF ≥470 msec unless approved by medical monitor
- Significant chronic lung diseases requiring oxygen therapy
- Pregnancy or lactation
- Major surgery within 4 weeks before first dose (except vascular access placement)
- History of allogeneic organ transplantation (except cornea)
- Allogeneic hematopoietic stem cell transplantation within 6 months or graft-versus-host disease grade ≥1
- Prior chimeric antigen receptor T-cell or other modified T cell therapy
- Active uncontrolled bacterial, fungal, or viral infections including hepatitis B, hepatitis C, HIV or AIDS-related illnesses (controlled infections allowed if viral load negative)
- Psychological, familial, sociological, or geographical conditions preventing protocol compliance or follow-up
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Trial Site Locations
Total: 8 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
The University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
6
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
8
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
L
Laurie F Graham, RN, MSN
CONTACT
H
Haris Durutlic
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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