CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplast
CLN-049-001 is a Phase 1, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
| Condition(s) | Relapsed/Refractory Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | CLN-049-001 is a Phase 1, open-label, multicenter, first-in-human trial of CLN-049 in patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) |
| Who can participate | Inclusion Criteria: 1. Aged ≥ 18 years of age. 2. Willing and able to give written informed consent and adhere to protocol requirements; written informed consent and any locally required authorization must be obtained from the patient prior to performing any protocol-related procedures, including screening evaluations, and serial samples of bone marrow and peripheral blood. 3. Patient has a confirmed diagnosis of recurrent or refractory AML or MDS. 4. Patient has received, and has progressed, recurred, or is intolerant of approved therapeutic options that are available, or declines treatment with these therapies. 5. White blood cell (WBC) count at the time of the first dose is \< 20,000/uL (hydroxyurea is permitted according to standard institutional practice). Following first dose, WBC sh |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Cullinan Therapeutics Inc. |
| Locations | Birmingham, Alabama, United States; Los Angeles, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States (+5 more sites) |
| Start date | 2021-11-18 |
| NCT ID | NCT05143996 |
| Official listing | https://clinicaltrials.gov/study/NCT05143996 |