Study on CTX-712 for Treating Relapsed or Hard-to-Treat Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes

Sponsor: Chordia Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05732103

Provider View

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

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.

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