CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Leukemia
Myelodysplastic Syndromes (MDS)
18 Years and older, Male and Female
CLN-049-001 (primary)
NCI-2021-13598
2020-005195-35
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)
Objectives
This trial is divided into 3 parts:
Part A - Single Ascending Dose (SAD) - Patients will receive a single dose of CLN-049 via IV
administration and be followed for safety for 28 days
Part B - Multiple Ascending Dose (MAD) - Patients will received CLN-049 every 7 days (q7d)
after an initial Lead-In Dose via IV administration and be followed for safety for 28 days
and will then enter long-term follow-up for up to 2 years
Part C - Multiple Ascending Dose (MAD) - Patients will receive CLN-049 q7d via SC injection
and be followed for safety for 28 days and will then enter long-term follow-up for up to 2
years
The SC injection cohorts will be initiated first, followed by IV administration cohorts
Eligibility
- Aged = 18 years of age.
- 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.
- Patient has a confirmed diagnosis of recurrent or refractory AML or MDS.
- Patient has received, and has progressed, recurred, or is intolerant of approved therapeutic options that are available, or declines treatment with these therapies.
- 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 should be checked prior to subsequent CLN-049 administration and if WBC > 20,000/µL, CLN-049 treatment should be postponed (see Section 6.1 for further guidance).
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2.
- Toxicities related to prior study therapy should have resolved to Grade 1 or less according to criteria of NCI CTCAE v5.0, except for alopecia, lymphopenia, neutropenia, leukopenia, anemia, thrombocytopenia. Patients with chronic but stable toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.
- The patient's laboratory values meet the following criteria:
- Creatinine clearance (CrCl) as calculated by the Cockcroft-Gault formula (Appendix 1) must be = 60 mL/min;
- Total bilirubin = 1.5 × ULN. This does not apply for patients with confirmed Gilbert's Syndrome, hemolysis, or chronic blood transfusions, for whom total bilirubin must be less than 3.0 mg/dL with a conjugated bilirubin less than 0.5 mg/dL;
- AST and ALT = 3.0 × ULN (unless attributed to leukemic involvement).
Treatment Sites in Georgia
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