Mithun V. Shah, M.D., Ph.D.

Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.

The purpose of this study is to evaluate safety and effectiveness of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. 

The main objective of this study is to evaluate the effectiveness of venetoclax in combination with azacitidine to improve Relapse Free Survival (RFS) in AML patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the effectiveness and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

**Please note that at Mayo Clinic, this study will only be enrolling in Part 2 of the trial and will not be enrolling adolescents. We will be enrolling adult subjects only. 

The purpose of this study is to assess SNDX-6352, or Axatilimab, for individuals who have active chronic recurrent or refractory Graft versus Host Disease (cGVHD) whom have used at least two previous treatments and have not had an improvement in symptoms. This study evaluates the effectiveness, safety, and tolerability of axatilimab at three different dose levels. Participants can receive axatilimab for up to two years and could be in the study up to 28 months.

The purpose of this study is to explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and effectiveness of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.

The purpose of this study is to determine the maximum tolerated dose (MTD) of KO-539, a menin-MLL(KMT2A) inhibitor, in patients with refractory or relapsed  acute myeloid leukemia (AML) who have failed or are ineligible for any approved standard of care therapies, including hematopoietic stem cell transplantation (HSCT).

The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for FLT3 AML.