WithdrawnPhase 1

IIT PH1 KDS-1001 in Patients With CML

Stopped: Study halted prematurely, prior to enrollment of first participant.

0Started 2024-12

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with non-blast phase CML by standard definition. This should be confirmed by presence of the Philadelphia chromosome or variants of the (9;22) translocation by cytogenetics, FISH or with a positive RT-PCR for BCR-ABL. Repeat marrow not required for enrollment although documentation of current chronic phase disease is required.
✓. \<15% blasts in peripheral blood and marrow
✓. \<30% blasts plus promyelocytes in peripheral blood and marrow
✓. \<20% basophils in peripheral blood
✓. \>100 x 109/L platelets
✓. No evidence of extramedullary leukemic involvement with the exception of hepatosplenomegaly.
✓. \<30% blasts in blood, marrow or both
✓. No evidence of extramedullary leukemic involvement with the exception of hepatosplenomegaly.

Exclusion criteria

✕. Current blast crisis phase disease by standard definition from the NCCN
✕. Pregnant or lactating females
✕. On other investigational agents for CML within 4 weeks of study enrollment
✕. Platelets of \<50,000/mm3, ANC \<500/mm3 or hemoglobin \< 7.5 g.dL
✕. Abnormal screening laboratory values as defined below:
✕. AST (SGOT) and/or ALT (SGPT) and/or alkaline phosphatase ≥ 5 x upper limit of normal (ULN)
✕. Total bilirubin \>1.5 x ULN (unless related to Gilbert´s or Meulengracht disease or leukemic infiltration)
✕. Creatinine ≥ 3 ULN or creatinine clearance \< 50 mL/min (calculated)

What they're measuring

Molecular Response

Timeframe: End of Treatment up to two weeks

Safety of KDS-1001

Timeframe: End of Study up to two years

Trial details

NCT IDNCT04808115

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More CML (Chronic Myelogenous Leukemia trials