A Phase I Study of CYNK-001 Immunotherapy in Adults with Acute Myeloid Leukemia in Remission with Small Amounts Remaining in the Blood

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Full Title

A Phase 1 Multi-Dose Study of Human Placental Hematopoeitic Stem Cell Derived Natural Killer Cells (CYNK-001) in Adults with Primary or Secondary Acute Myeloid Leukemia (AML) in Morphologic Complete Remission with Minimal Residual Disease (MRD)

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy CYNK-001 that can be given safely in patients with acute myeloid leukemia (AML) that is in “morphologic complete remission” with minimal residual disease (MRD). Morphologic complete remission occurs when white blood cell and platelet counts are within the normal range and the amount of leukemia cells is below 5 percent in a bone marrow sample. MRD means there is still a small number of leukemia cells remaining in the bloodstream.

AML with MRD is often resistant to treatment and has a high chance of coming back. CYNK-001 is a cellular therapy made of healthy donated cells called natural killer (NK) cells. The NK cells are taken from human placenta and grown in a laboratory. There are proteins in NK cells that can kill cancer cells. CYNK-001 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have AML in morphologic complete remission and MRD.
  • Patients should recover from the serious side effects of prior therapies.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18-80.

For more information about this study and to inquire about eligibility, please contact Dr. Aaron Goldberg at 646-608-3752.

Protocol

20-297

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators