Acute Myeloid LeukemiaPhase 1/2NCT03068819
Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant
A Phase 1/2 study testing CIML NK Cell Infusion, CD3+ T Cell Product Infusion and Leukapheresis in people with Acute Myeloid Leukemia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Donor Lymphocyte Infusion (DLI) following salvage chemotherapy is the one of the most widely used treatment approaches in patients who relapse after allogeneic hematopoietic cell transplant (allo-HCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- CIML NK Cell Infusion, CD3+ T Cell Product Infusion and Leukapheresis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2017to 15 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Recipient Inclusion Criteria:
- Relapsed AML after HLA-matched related or unrelated allogeneic hematopoietic cell transplant
- For pilot pediatric/young adult patient cohort ≥1 and <18 years of age
- For phase 2 adult patient cohort ≥18 years of age
- Available original donor (same donor as used for the initial stem cell transplant) that is willing and eligible for non-mobilized collection
- Patients with known central nervous system (CNS) involvement with AML are eligible provided that they have been treated and cerebrospinal fluid (CSF) is clear for at least 2 weeks prior to enrollment into the study. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment.
- Karnofsky performance status > 60 %
- Adequate organ function as defined below:
- Total bilirubin < 2 mg/dL
- AST(SGOT)/ALT(SGPT) < 3.0 x IULN
- Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m2 by Cockcroft-Gault Formula
- Oxygen saturation ≥90% on room air
- Not currently requiring systemic corticosteroid therapy (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) or any other immune suppressive medications
- Women of childbearing potential must have a negative pregnancy test within 28 days prior to study registration. Female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study including throughout the initial evaluation period (100 days after CIML NK cell infusion).
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Recipient Exclusion Criteria:
- Acute or chronic GvHD with ongoing active systemic treatment.
- Circulating blast count >10,000/uL by morphology or flow cytometry (cyto-reductive therapies, including salvage chemotherapy, is encouraged prior to study enrollment)
- Uncontrolled bacterial or viral infections, or known HIV, Hepatitis B, or Hepatitis C infection.
- Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.
- New or progressive pulmonary infiltrates concerning for new or uncontrolled infectious process.
- Known hypersensitivity to one or more of the study agents
- Received any investigational drugs within the 14 days prior to CIML NK cell infusion date
- Pregnant and/or breastfeeding
Donor Inclusion Criteria:
- At least 18 years of age
- Same donor as used for the allo-HCT
- In general good health, and medically able to tolerate leukapheresis
- Ability to understand and willingness to sign an IRB approved written informed consent document
Donor Exclusion Criteria:
- Active hepatitis, positive for HTLV, or HIV on donor viral screen
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant in Children and Adults
Donor Lymphocyte Infusion (DLI) following salvage chemotherapy is the one of the most widely used treatment approaches in patients who relapse after allogeneic hematopoietic cell transplant (allo-HCT). However, the complete remission (CR) rates and long term survival remain very poor in these patients and, therefore, there is an unmet need to develop more effective treatment approaches in patients who relapse after allo-HCT.
Based on the initial promising results with our ongoing cytokine-induced memory-like (CIML) natural killer (NK) cell trial, the investigators hypothesize that combining the CIML NK cells with DLI approach will significantly enhance the graft versus leukemia and therefore potentially provide potentially curative therapy for these patients with otherwise extremely poor prognosis. Combining CIML NK cells with the DLI platform will also potentially allow these adoptively transferred cells to persist for longer duration as they should not be rejected by donor T cells as the CIML NK cells are derived from the same donor. The use of CIML NK cells is unlikely to lead to excessive graft versus host disease (GVHD) as previous studies have not been associated with excessive GVHD rates.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- CIML NK Cell Infusion, CD3+ T Cell Product Infusion, Leukapheresis
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIML NK Cell InfusionDrug
Day 0 and possible second cycle > 30 days after the first course
CD3+ T Cell Product InfusionProcedure or surgery
Also called DLI
Day -1 and possible second cycle > 30 days after the first course (Pilot Pediatric/Young Adult Cohort).
Day 30 and possible second cycle >30 days after the first course (Phase 2 Adult Cohort)
LeukapheresisProcedure or surgery
On Day -2 or -1
| Study group | Role | What they receive |
|---|---|---|
| CIML NK cell after T cell DLI (Pilot Pediatric/Young Adult Cohort) | Experimental | * Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. Receives: Drug: CIML NK Cell Infusion; Procedure: CD3+ T Cell Product Infusion; Procedure: Leukapheresis |
| CIML NK cell after T cell DLI (Phase 2 Adult Cohort) | Experimental | * Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0. Receives: Drug: CIML NK Cell Infusion; Procedure: CD3+ T Cell Product Infusion; Procedure: Leukapheresis |
| Donors | Other | On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort. Receives: Procedure: Leukapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Successfully Generating CIML NK Cells With Standard of Care (SOC) DLI From the Original Stem Cell Donor as Measured by the Number of Participants That Had Successful Doses Infused (Pilot Pediatric/Young Adult Cohort)
-Feasibility is defined as the ability to generate and successfully infuse CIML NK cells with SOC donor lymphocyte infusion (DLI). Will be considered successful if doses above the minimum can be delivered in at least 18 of 24 patients. Target and minimum CIML doses are maximum capped at 20x10^6/kg with a minimum dose of 0.5x10^6 kg.
Measured: Completion of all recipients through Day 0
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Pilot Pediatric/Young Adult Cohort)
Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.
Measured: Up to Day 100
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable Graft Versus Host Disease (GVHD) (Pilot Pediatric/Young Adult Cohort)
Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.
Measured: From day 14 through month 6
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Pilot Pediatric/Young Adult Cohort)
Prolonged neutropenia is defined as an absolute neutrophil count <500/μL persisting for > 2 weeks.
Measured: 8 weeks post CIML NK infusion
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Phase 2 Adult Cohort)
Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.
Measured: Up to Day 100
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable GVHD (Phase 2 Adult Cohort)
Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.
Measured: From day 14 through month 6
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Phase 2 Adult Cohort)
Prolonged neutropenia is defined as an absolute neutrophil count <500/μL persisting for > 2 weeks.
Measured: 8 weeks post CIML NK infusion
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Measured: 6 months
Secondary outcomes (16)
Complete Remission Rate (CR/CRi) (Pilot Pediatric/Young Adult Cohort)
- Complete remission (CR):Morphologically leukemia free state (i.e. bone marrow with <5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions
- Complete remission with incomplete blood count recover (CRi): All of the above criteria for CR must be met, except that absolute neutrophils <1000 /μL or platelets <100,000 /μL in the blood.
Measured: Day 30
Complete Remission Rate (CR/CRi) (Phase 2 Adult Cohort)
- Complete remission (CR):Morphologically leukemia free state (i.e. bone marrow with <5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions
- Complete remission with incomplete blood count recover (CRi): All of the above criteria for CR must be met, except that absolute neutrophils <1000 /μL or platelets <100,000 /μL in the blood.
Measured: Day 30
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Pilot Pediatric/Young Adult Cohort)
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Measured: 100 days post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Pilot Pediatric/Young Adult Cohort)
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Measured: 1 year post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Measured: 100 days post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Measured: 1 year post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Pilot Pediatric/Young Adult Cohort)
-OS is defined as the time from the date of Day 0 until death from any cause.
Measured: 100 days post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Pilot Pediatric/Young Adult Cohort)
-OS is defined as the time from the date of Day 0 until death from any cause.
Measured: 1 year post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Phase 2 Adult Cohort)
-OS is defined as the time from the date of Day 0 until death from any cause.
Measured: 100 days post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Phase 2 Adult Cohort)
-OS is defined as the time from the date of Day 0 until death from any cause.
Measured: 1 year post CIML NK cell infusion
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Pilot Pediatric/Young Adult Cohort)
- Incidence and severity of acute GVHD will be assessed based on the Minnesota grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
- The Minnesota Grading scale is graded with I, II, III, IV. Grade I is the least severe and Grade IV is the most severe.
Measured: Day 14 through 6 months
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Pilot Pediatric/Young Adult Cohort)
- Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
- The CIBMTR grading scale is graded with A, B, C, or D. Grade A is considered the least severe with Grade D being the most severe.
Measured: Day 14 through 6 months
Incidence and Severity of Chronic GVHD Rates (Pilot Pediatric/Young Adult Cohort)
- Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
- Severity is graded with mild, moderate, or severe chronic GVHD.
Measured: Day 100 through 12 months
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Phase 2 Adult Cohort)
- Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
- The Minnesota Grading scale is graded with I, II, III, IV. Grade I is the least severe and Grade IV is the most severe.
Measured: Day 14 through 6 months
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Phase 2 Adult Cohort)
- Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
- The CIBMTR grading scale is graded with A, B, C, or D. Grade A is considered the least severe with Grade D being the most severe.
Measured: Day 14 through 6 months
Incidence and Severity of Chronic GVHD Rates (Phase 2 Adult Cohort)
- Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).
- Severity is graded with mild, moderate, or severe chronic GVHD.
Measured: Day 100 through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start23 Oct 2017
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Allotera Therapeutics, Children's Discovery Institute
- Responsible party
- Sponsor
- Investigators
- Amanda Cashen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068819
- Sponsor's protocol ID
- 202206197
- Other IDs
- P50CA171963
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2017
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bednarski JJ, Zimmerman C, Berrien-Elliott MM, Foltz JA, Becker-Hapak M, Neal CC, Foster M, Schappe T, McClain E, Pence PP, Desai S, Kersting-Schadek S, Wong P, Russler-Germain DA, Fisk B, Lie WR, Eisele J, Hyde S, Bhatt ST, Griffith OL, Griffith M, Petti AA, Cashen AF, Fehniger TA. Donor memory-like NK cells persist and induce remissions in pediatric patients with relapsed AML after transplant. Blood. 2022 Mar 17;139(11):1670-1683. doi: 10.1182/blood.2021013972.
PubMed 34871371
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant in Children and Adults
- ClinicalTrials.gov ID
- NCT03068819
- Acronym / sponsor ID
- 202206197
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Allotera Therapeutics, Children's Discovery Institute
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Donor Lymphocyte Infusion (DLI) following salvage chemotherapy is the one of the most widely used treatment approaches in patients who relapse after allogeneic hematopoietic cell transplant (allo-HCT). However, the complete remission (CR) rates and long term survival remain very poor in these patients and, therefore, there is an unmet need to develop more effective treatment approaches in patients who relapse after allo-HCT.
Based on the initial promising results with our ongoing cytokine-induced memory-like (CIML) natural killer (NK) cell trial, the investigators hypothesize that combining the CIML NK cells with DLI approach will significantly enhance the graft versus leukemia and therefore potentially provide potentially curative therapy for these patients with otherwise extremely poor prognosis. Combining CIML NK cells with the DLI platform will also potentially allow these adoptively transferred cells to persist for longer duration as they should not be rejected by donor T cells as the CIML NK cells are derived from the same donor. The use of CIML NK cells is unlikely to lead to excessive graft versus host disease (GVHD) as previous studies have not been associated with excessive GVHD rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CIML NK cell after T cell DLI (Pilot Pediatric/Young Adult Cohort) | Experimental | Drug: CIML NK Cell Infusion, Procedure: CD3+ T Cell Product Infusion, Procedure: Leukapheresis* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0. * A second cycle of therapy may be administered > 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. |
| CIML NK cell after T cell DLI (Phase 2 Adult Cohort) | Experimental | Drug: CIML NK Cell Infusion, Procedure: CD3+ T Cell Product Infusion, Procedure: Leukapheresis* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated. * A 2nd cycle of therapy may be administered > 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0. |
| Donors | Other | Procedure: LeukapheresisOn Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CIML NK Cell InfusionDay 0 and possible second cycle > 30 days after the first course | Drug | CIML NK cell after T cell DLI (Phase 2 Adult Cohort), CIML NK cell after T cell DLI (Pilot Pediatric/Young Adult Cohort) |
| CD3+ T Cell Product InfusionAlso: DLIDay -1 and possible second cycle > 30 days after the first course (Pilot Pediatric/Young Adult Cohort). Day 30 and possible second cycle >30 days after the first course (Phase 2 Adult Cohort) | Procedure or surgery | CIML NK cell after T cell DLI (Phase 2 Adult Cohort), CIML NK cell after T cell DLI (Pilot Pediatric/Young Adult Cohort) |
| LeukapheresisOn Day -2 or -1 | Procedure or surgery | CIML NK cell after T cell DLI (Phase 2 Adult Cohort), CIML NK cell after T cell DLI (Pilot Pediatric/Young Adult Cohort), Donors |
Primary outcome
Feasibility of Successfully Generating CIML NK Cells With Standard of Care (SOC) DLI From the Original Stem Cell Donor as Measured by the Number of Participants That Had Successful Doses Infused (Pilot Pediatric/Young Adult Cohort)
Time frame: Completion of all recipients through Day 0
-Feasibility is defined as the ability to generate and successfully infuse CIML NK cells with SOC donor lymphocyte infusion (DLI). Will be considered successful if doses above the minimum can be delivered in at least 18 of 24 patients. Target and minimum CIML doses are maximum capped at 20x10^6/kg with a minimum dose of 0.5x10^6 kg.
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Pilot Pediatric/Young Adult Cohort)
Time frame: Up to Day 100
Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable Graft Versus Host Disease (GVHD) (Pilot Pediatric/Young Adult Cohort)
Time frame: From day 14 through month 6
Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Pilot Pediatric/Young Adult Cohort)
Time frame: 8 weeks post CIML NK infusion
Prolonged neutropenia is defined as an absolute neutrophil count <500/μL persisting for > 2 weeks.
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Phase 2 Adult Cohort)
Time frame: Up to Day 100
Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable GVHD (Phase 2 Adult Cohort)
Time frame: From day 14 through month 6
Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Phase 2 Adult Cohort)
Time frame: 8 weeks post CIML NK infusion
Prolonged neutropenia is defined as an absolute neutrophil count <500/μL persisting for > 2 weeks.
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
Time frame: 6 months
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
16 secondary outcomes
Complete Remission Rate (CR/CRi) (Pilot Pediatric/Young Adult Cohort)
Time frame: Day 30
Complete Remission Rate (CR/CRi) (Phase 2 Adult Cohort)
Time frame: Day 30
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Pilot Pediatric/Young Adult Cohort)
Time frame: 100 days post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Pilot Pediatric/Young Adult Cohort)
Time frame: 1 year post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
Time frame: 100 days post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
Time frame: 1 year post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Pilot Pediatric/Young Adult Cohort)
Time frame: 100 days post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Pilot Pediatric/Young Adult Cohort)
Time frame: 1 year post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Phase 2 Adult Cohort)
Time frame: 100 days post CIML NK cell infusion
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Phase 2 Adult Cohort)
Time frame: 1 year post CIML NK cell infusion
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Pilot Pediatric/Young Adult Cohort)
Time frame: Day 14 through 6 months
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Pilot Pediatric/Young Adult Cohort)
Time frame: Day 14 through 6 months
Incidence and Severity of Chronic GVHD Rates (Pilot Pediatric/Young Adult Cohort)
Time frame: Day 100 through 12 months
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Phase 2 Adult Cohort)
Time frame: Day 14 through 6 months
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Phase 2 Adult Cohort)
Time frame: Day 14 through 6 months
Incidence and Severity of Chronic GVHD Rates (Phase 2 Adult Cohort)
Time frame: Day 100 through 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34871371Bednarski JJ, Zimmerman C, Berrien-Elliott MM, Foltz JA, Becker-Hapak M, Neal CC, Foster M, Schappe T, McClain E, Pence PP, Desai S, Kersting-Schadek S, Wong P, Russler-Germain DA, Fisk B, Lie WR, Eisele J, Hyde S, Bhatt ST, Griffith OL, Griffith M, Petti AA, Cashen AF, Fehniger TA. Donor memory-like NK cells persist and induce remissions in pediatric patients with relapsed AML after transplant. Blood. 2022 Mar 17;139(11):1670-1683. doi: 10.1182/blood.2021013972.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Amanda Cashen, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CIML NK Cell Infusion, CD3+ T Cell Product Infusion and Leukapheresis in people with Acute Myeloid Leukemia, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Successfully Generating CIML NK Cells With Standard of Care (SOC) DLI From the Original Stem Cell Donor as Measured by the Number of Participants That Had Successful Doses Infused (Pilot Pediatric/Young Adult Cohort) (time frame: Completion of all recipients through Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068819, which also lists 1 linked publication.
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 24 Apr 2026.