NCT04808115

IIT PH1 KDS-1001 in Patients With CML

A Phase I Trial of Incorporating Natural Killer (K-NK) Cells for Patients With Chronic Myeloid Leukemia (CML) and Molecular Residual Disease After Tyrosine Kinase Inhibitor (TKI) Therapy

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This open label, non-randomized, prospective phase I study is designed to evaluate if the addition of natural killer cell therapy (KDS-1001) to tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML) patients with persistent or recurrent molecular residual disease (MRD) after at least one year of TKI therapy will allow patients to achieve RT-PCR negativity (MRD negative). This may have implications for future TKI cessation studies.

Conditions

• CML (Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	KDS-1001	Cycles 1-6 (14 days per cycle) 1 x 109/KDS-1001 cells/infusion administered on day 1 of each cycle

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-12-01
• Completion: 2029-12-01
• First posted: 2021-03-22
• Last updated: 2024-11-26

Regulatory

• FDA-regulated drug study