- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Caitlyn Campbell
- Phone Number: 919-668-5660
- Email: caitlyn.campbell@duke.edu
Study Contact Backup
- Name: Lynn Volk
- Phone Number: 919-668-1092
- Email: lynn.volk@duke.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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.
- Detectable BCR-ABL transcripts measured by RT-PCR at a CLIA-approved laboratory and reported on the IS with a value of >0.01% within 28 days prior to study enrollment. The chosen RT-PCR test must be sensitive enough to detect a 4.5 log reduction in BCR/ABL transcripts measured in peripheral blood.
- Performance status must be ECOG PS 0, 1, or 2.
- Woman of childbearing potential and is willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of protocol-specified therapy. Male who has a female partner of childbearing potential, and is willing to use 2 highly effective forms of contraception for at least an additional 3 months after the last dose of protocol-specified therapy.
Exclusion Criteria:
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
- Steroids as premedication for hypersensitivity reactions at physiologic doses ≤10 mg/day of prednisone or equivalent
- Patients with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise tolerance or compliance to this protocol.
- Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy
- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, deep vein thrombosis, or symptomatic pulmonary embolism
- Known prior or suspected hypersensitivity to study drugs or any component in their formulations
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- Diagnosis of any other malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms
- Active infection requiring systemic therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KDS-1001
KDS-1001 is infused on Day 1 of each 14 day cycle.
Patients will receive 6 cycles of KDS-1001 treatment.
|
Cycles 1-6 (14 days per cycle) 1 x 109/KDS-1001 cells/infusion administered on day 1 of each cycle |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Molecular Response
Time Frame: End of Treatment up to two weeks
|
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
Time Frame: End of Study up to two years
|
Number of adverse events as measured by self report
|
End of Study up to two years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lindsay Rein, MD, Assistant Professor of Medicine, Hematologic Malignancies & Cell Therapy
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00106898
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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