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

NCT05115630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-19

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jeremy Ramdial, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2025-05-15
Completion
2025-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05115630 on ClinicalTrials.gov