NCT05115630

Off-the-shelf NK Cells + SCT for Myeloid Malignancies

A Phase I/II Clinical Trial of "Off-the-shelf" NK Cell Administration in Combination With Allogeneic SCT to Decrease Disease Relapse in Patients With High-risk Myeloid Malignancies Undergoing Matched Related, Matched Unrelated, One Antigen Mismatched Unrelated, or Haploidentical Stem-cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective Assess the safety and effectiveness of "off the shelf" third party NK cells in combination with allogeneic SCT in patients with myeloid malignancies. Secondary Objectives To assess NK cell related toxicities To estimate the proportion of patients with engraftment/graft failure. To assess the rate of leukemia relapse, disease-free survival (DFS), overall survival (OS), and GVHD-free, Relapse-free survival (GRFS) after transplantation by one year. To estimate the non-relapse mortality (NRM) at day 100, day 180 and 1 year post-transplant. To estimate the cumulative incidence of grade 2-4 and grades 3-4 aGVHD at day 100. To assess the rate of chronic GVHD within the first-year post transplantation. To assess rate of BK, CMV, and Adenovirus infections. To assess MRD. To assess immune reconstitution post-transplant

Conditions

• Myeloid Malignancies
• Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given by IV
DRUG	Mesna	Given by IV
DRUG	Filgrastim	Given by IV
DRUG	Melphalan	Given by IV
DRUG	Fludarabine phosphate	Given by IV
DRUG	Tacrolimus	Given by IV
DRUG	Mycophenolate mofetil	Given by IV
DRUG	Total Body Irradiation One Dose	Given by IV

Timeline

• Start date: 2022-04-08
• Primary completion: 2025-05-15
• Completion: 2025-05-15
• First posted: 2021-11-10
• Last updated: 2025-12-19
• Results posted: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study