IIT PH1 KDS-1001 in Patients With CML

NCT04808115 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: Pro00106898
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Molecular Response

  At least one (1) log reduction in IS OR negative to at least MR4.5 via PCR-based testing

  End of Treatment up to two weeks

• Safety of KDS-1001

  Number of adverse events as measured by self report

  End of Study up to two years

Study Arms (1)

KDS-1001

EXPERIMENTAL

KDS-1001 is infused on Day 1 of each 14 day cycle. Patients will receive 6 cycles of KDS-1001 treatment.

Drug: KDS-1001

Interventions

KDS-1001 DRUG

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

KDS-1001

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Chronic Phase CML is defined as follows:
• \<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.
• Accelerated Phase CML is defined as follows:
• \<30% blasts in blood, marrow or both
• No evidence of extramedullary leukemic involvement with the exception of hepatosplenomegaly.
• \> 18 years of age and able to provide informed consent
• Patients must have been on TKI therapy for CML for at least 1 year prior to enrollment at minimum goal doses.
• Imatinib 300mg PO daily Dasatinib 70mg PO daily Nilotinib 200mg PO BID Bosutinib 300mg PO daily Ponatinib 30mg PO daily Lower than goal doses are allowed IF documented by the treating physician that the goal dose was not tolerable due to toxicity.
• Patient must have been on their most recent TKI consistently for at least 6 months prior to enrollment on study
• Must be expected to remain on current TKI for at least 6 months following last infusion, unless there is progression of disease.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• 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)
• Those with residual toxicity of \>grade 1 from prior therapy in areas that may be expected to worsen over time; those with residual toxicities of grade 2 which are stable prior to enrollment and the natural history of which would be expected to be 'no change' over time are allowed; those with grade 3 or 4 residual toxicities are not.
• Positive test for human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)
• Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or chronic infection (those with prior infection that is now post treatment and PCR negative are allowed)
• Current use of immunosuppressive medications at the time of study enrollment and within 2 weeks of any study treatments, except:
• Intranasal, inhaled, topical steroids, or local steroid injection
• Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent

Sponsors & Collaborators

• Duke University: lead
• Kiadis Pharma: collaborator

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lindsay Rein, MD

  Assistant Professor of Medicine, Hematologic Malignancies & Cell Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 22, 2021
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share