CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Must have received: approved therapeutic options

Patient has received, and has progressed, recurred, or is intolerant of approved therapeutic options that are available, or declines treatment with these therapies.

Cannot have received: allogeneic hematopoietic transplantation

Exception: allowed if >6 months since transplant, no GVHD, and no ongoing immunosuppression within 2 months of first dose

Allogeneic hematopoietic transplantation within six months of treatment, or with clinical or laboratory evidence of GVHD, or requiring ongoing treatment with immune suppression within 2 months of the first dose of CLN-049.

Cannot have received: radiation therapy

Exception: allowed if >28 days since XRT, >8 weeks since craniospinal XRT, and no history of total body irradiation (TBI)

Radiation therapy (XRT) within 28 days of the first dose of CLN049, or craniospinal XRT within 8 weeks of the first dose of CLN-049, or history of total body irradiation (TBI).

Cannot have received: checkpoint inhibitor

Exception: allowed if >42 days since prior immunotherapy

Prior immunotherapy with checkpoint inhibitors ≤ 42 days prior to the first dose of CLN-049.

Cannot have received: CAR-T cell therapy

Prior history of chimeric antigen receptor (CAR-T) cell therapy or other modified T cell therapy.

Cannot have received: anti-leukemic therapy

Exception: hydroxyurea for cytoreduction and intrathecal chemotherapy allowed if >14 days or 5 half-lives (whichever is shorter) prior to first dose

Anti-leukemic therapy except hydroxyurea for cytoreduction, and intrathecal chemotherapy ≤ 14 days or 5 half-lives, whichever is shorter, prior to the first dose of CLN-049.

Cannot have received: short-acting hematopoietic growth factors

Exception: allowed if >7 days prior to first dose

Short-acting hematopoietic growth factors ≤ 7 days prior to the first dose of CLN-049

Cannot have received: long-acting growth factors

Exception: allowed if >14 days prior to first dose

Long-acting growth factors ≤ 14 days prior to the first dose of CLN-049.

Cannot have received: systemic glucocorticoid therapy or other immune-suppressive drugs

Exception: allowed if ≤ equivalent of <10 mg prednisone daily, or topical/eye drops, or for transfusion premedication/infusion reactions

Systemic glucocorticoid therapy (except equivalent of < 10 mg prednisone daily) or other immune-suppressive drugs ≤ 14 days prior to the first dose of CLN-049 (see separate guidelines for patients who are post allogeneic hematopoietic transplantation). The transient use of corticosteroids for transfusion premedication or the treatment of infusion or transfusion reactions will not be considered for this criterion. Topical corticosteroids and steroid eye drops are allowed, and will not exclude the patient from eligibility.

Cannot have received: FLT3-directed bispecific molecule

Prior treatment with a FLT3-directed bispecific molecule, or a FLT3-targeted antibody.

Cannot have received: investigational drug

Exception: allowed if >14 days or 5 half-lives (whichever is longer) prior to first dose

Currently participating/previously participated in an interventional study and received an investigational drug within 14 days (or five half-lives, whichever is longer) prior to the first dose of CLN-049.