Study on CTX-712 for Treating Relapsed or Hard-to-Treat Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
Sponsor: Chordia Therapeutics, Inc.
ClinicalTrials ID:NCT05732103
This clinical trial is testing a new drug, CTX-712, to see if it is safe and effective for patients with relapsed or difficult-to-treat acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (HR-MDS).
Patient Parameters
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Program Overview
The study is designed to evaluate the safety and effectiveness of a new drug called CTX-712 in patients with relapsed or hard-to-treat acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (HR-MDS). It is divided into two phases. In Phase 1, the study will determine the best dose of CTX-712 by gradually increasing the dose given to patients. Once the best dose is found, a small group of patients will receive this dose to confirm its safety. In Phase 2, the study will focus on how well CTX-712 works in treating the conditions and further confirm its safety.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a diagnosis of acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (HR-MDS), or certain related conditions.
- Have received 1 to 4 previous treatments for these conditions.
- Have good organ function based on specific blood test results.
- Have a performance status score of 2 or less, indicating the ability to carry out daily activities with some limitations.
- Women who can become pregnant must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 4 months after.
- Men with partners who can become pregnant must agree to use effective birth control or abstain from sex during the study and for 4 months after.
Exclusion Criteria
- Have a diagnosis of acute promyelocytic leukemia.
- Have a relapse that is only outside the bone marrow (for Phase 2 only).
- Have active leukemia in the central nervous system.
- Have a history of other cancers.
- Have certain heart or lung conditions, such as recent heart attack, severe heart failure, or serious lung disease.
- Are pregnant or breastfeeding.
- Have had major surgery within 4 weeks before starting the study.
- Have had an organ transplant (except cornea) or a stem cell transplant within 6 months.
- Have had certain types of cell therapy.
- Have an active, uncontrolled infection, including hepatitis B or C, or HIV.
- Have any conditions that would make it difficult to follow the study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic Florida | 32224 | Jacksonville | Florida |
| Mayo Clinic Comprehensive Cancer Center | 55905 | Rochester | Minnesota |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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