Off-the-shelf NK Cells + SCT for Myeloid Malignancies (NCT05115630) | Clinical Trial Compass
CompletedPhase 2
Off-the-shelf NK Cells + SCT for Myeloid Malignancies
United States24 participantsStarted 2022-04-08
Plain-language summary
The goal of this clinical research study is to learn about the safety and effectiveness of giving KDS-1001 in combination with a standard stem cell transplant to patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML). KDS-1001 is a study product created using certain immune cells called natural killer (NK) cells collected from a third-party donor.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients ages 18 to 70 years old at the time of enrollment.
✓. Patients weighing at least 42 kg
✓. Patient with the hematologic malignancies described below, as well as an HLA matched related donor, HLA matched unrelated donor, a haploidentical related donor, or a one antigen mismatched unrelated donor. HLA matching includes HLA A, B, C, and DR-B1.
✓. Patients must have one of the following diseases:
✓. Primary induction failure with partial response to therapy who achieve adequate cytoreduction
✓. Aplastic/hypoplastic marrow with or without detectable persistent disease after induction chemotherapy or after salvage chemotherapy
✓. Failed to achieve cytogenetic remission or have cytogenetic relapse after treatment with at least 2 tyrosine kinase inhibitors, or
✓. Accelerated phase or blast phase at any time, or
Exclusion criteria
✕. HIV positive; active hepatitis B or C.
✕. Uncontrolled infections; PI is the final arbiter of this criterion.
✕. Liver cirrhosis.
✕. CNS involvement within 3 months prior to the transplant.
✕
What they're measuring
1
Number of Participants Who Experienced Graft Failure
. Positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
✕. Inability to comply with medical therapy or follow-up.
✕. Patient with a known history of allergic reactions to any constituents of the product, including a known history of allergic reactions to cellular products or DMSO.
✕. Other malignancy/cancer diagnosis with active disease or in remission and \<2 years ago, not including nonmelanoma skin cancer