CML (Chronic Myelogenous LeukemiaPhase 1NCT04808115
IIT PH1 KDS-1001 in Patients With CML
A Phase 1 study testing KDS-1001 in people with CML (Chronic Myelogenous Leukemia, run by Duke University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CML (Chronic Myelogenous Leukemia
- What is being tested?
- KDS-1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2029
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- 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
About this study
Official title: 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
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
- Being tested
- KDS-1001
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDS-1001Drug
Cycles 1-6 (14 days per cycle)
1 x 109/KDS-1001 cells/infusion administered on day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| KDS-1001 | Experimental | KDS-1001 is infused on Day 1 of each 14 day cycle. Patients will receive 6 cycles of KDS-1001 treatment. Receives: Drug: KDS-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Response
At least one (1) log reduction in IS OR negative to at least MR4.5 via PCR-based testing
Measured: End of Treatment up to two weeks
Safety of KDS-1001
Number of adverse events as measured by self report
Measured: End of Study up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startDec 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: Study halted prematurely, prior to enrollment of first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CML (Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Kiadis Pharma
- Responsible party
- Sponsor
- Investigators
- Lindsay Rein, MD, Principal investigator, Assistant Professor of Medicine, Hematologic Malignancies & Cell Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808115
- Sponsor's protocol ID
- Pro00106898
- Status last verified
- Nov 2024
- First submitted
- 24 Feb 2021
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04808115
- Acronym / sponsor ID
- Pro00106898
- Conditions
- CML (Chronic Myelogenous Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Kiadis Pharma
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KDS-1001 | Experimental | Drug: KDS-1001KDS-1001 is infused on Day 1 of each 14 day cycle. Patients will receive 6 cycles of KDS-1001 treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- > 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
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDS-1001Cycles 1-6 (14 days per cycle) 1 x 109/KDS-1001 cells/infusion administered on day 1 of each cycle | Drug | KDS-1001 |
Primary outcome
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
Safety of KDS-1001
Time frame: End of Study up to two years
Number of adverse events as measured by self report
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Rein, MD principal investigator
Assistant Professor of Medicine, Hematologic Malignancies & Cell Therapy
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KDS-1001 in people with CML (Chronic Myelogenous Leukemia, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular Response (time frame: End of Treatment up to two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.