Study on CLN-049 for Patients with Relapsed or Hard-to-Treat Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Sponsor: Cullinan Therapeutics Inc.
ClinicalTrials ID:NCT05143996
This clinical trial is testing a new drug, CLN-049, to see if it is safe and effective for patients with AML or MDS that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
This study is exploring a new treatment called CLN-049 for patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) that has come back or is not responding to other treatments. The trial is divided into several parts to test different doses and methods of giving the drug, and to find the best dose for future studies. Participants will receive the drug either through an IV or an injection and will be monitored for safety and effectiveness over time.
Description
The trial is divided into five parts:
- Part A: Participants receive a single dose of CLN-049 through an IV and are monitored for safety for 28 days.
- Part B: Participants receive multiple doses of CLN-049 through an IV every 7 days after an initial dose, followed by safety monitoring for 28 days and long-term follow-up for up to 2 years.
- Part C: Participants receive multiple doses of CLN-049 through an injection every 7 days, followed by safety monitoring for 28 days and long-term follow-up for up to 2 years.
- Part D: This phase involves testing two different dose regimens of CLN-049 through an IV to find the best dose. More participants will be enrolled at the best dose found.
- Part E: This phase tests the best dose of CLN-049 in newly diagnosed AML patients with a specific genetic mutation (TP53) who have not received prior treatment for AML.
Enrollment for Part A ended in May 2022, and for Part C in July 2024.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of AML or MDS that has returned or not responded to treatment.
- For Parts A, B, C: Must have AML or MDS that has not responded to or returned after treatment.
- For Part D: Must have AML that has not responded to or returned after no more than two treatments and have a specific genetic mutation (TP53).
- For Part E: Must have newly diagnosed AML with a specific genetic mutation (TP53) and no prior treatment.
- White blood cell count must be less than 20,000/uL at the start of treatment.
- Must be in good overall health with a performance status of 0 to 2.
- Must have certain lab values within specified limits, including kidney and liver function.
Exclusion Criteria
- Cannot have a diagnosis of acute promyelocytic leukemia (APL).
- Cannot have active leukemia in the central nervous system.
- Cannot have a relapse outside the bone marrow.
- Cannot have had an organ transplant.
- Cannot have had a bone marrow transplant within certain timeframes or with ongoing complications.
- Cannot have had recent radiation or certain other cancer treatments.
- Cannot have active infections or other serious medical conditions.
- Cannot have a history of severe allergic reactions to similar treatments.
- Cannot have certain viral infections or be pregnant or breastfeeding.
- Cannot have received a live vaccine recently.
- Cannot have certain heart conditions or other medical issues that might interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama O'Neal Cancer Center | 35233 | Birmingham | Alabama |
| Mayo Clinic Hospital - Phoenix | 85054 | Phoenix | Arizona |
| City of Hope | 91010 | Duarte | California |
| UCLA | 90095 | Los Angeles | California |
| UCHealth Anschutz Cancer Pavilion | 80045 | Aurora | Colorado |
| Mayo Clinic Hospital - Jacksonville | 32224 | Jacksonville | Florida |
| University of Miami Health System | 33136 | Miami | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Emory University Hospital | 30322 | Atlanta | Georgia |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
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