MedTrace Logo

IIT PH1 KDS-1001 in Patients With CML

NCT04808115 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-11-26

No results posted yet for this study

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

DRUG

KDS-1001

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

Sponsors & Collaborators

Principal Investigators

  • Lindsay Rein, MD · Assistant Professor of Medicine, Hematologic Malignancies & Cell Therapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Drug
Yes

More Related Trials

Entities

Companies

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 NCT04808115 on ClinicalTrials.gov