Acute Myeloid LeukemiaPhase 1NCT06138587
Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation
A Phase 1 study testing Cytokine Induced Memory-like Natural Killer Cells and Interleukin-2 in people with Acute Myeloid Leukemia and Leukemia, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Leukemia, Leukemia, Myeloid
- What is being tested?
- Cytokine Induced Memory-like Natural Killer Cells and Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jan 2024to 30 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Histologically or cytologically confirmed diagnosis of AML, MDS, or MDS/MPN that is at high risk for post-transplant relapse and that has measurable disease prior to transplant. Patients at high risk for post-transplant relapse include:
- De novo AML diagnosed at or after age 60, except CBF AML
- De novo AML in CR1 AND MRD+ by Hematologics Inc. flow cytometry pretransplant (this would be on the most recent pre-transplant bone marrow)
- Secondary AML
- AML with 5 - > 10% blasts at the time of transplant who are judged by their treating clinician and study PI to have no benefit from additional pre-transplant chemotherapy
- Any AML transplanted in CR2 or greater
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- TP53-mutated MDS or AML
- Therapy-related MDS or AML
- MDS with monosomy 7
- MDS with >= 5% blasts at the time of transplant
- MDS/MPN or CMML
- Adequate organ function within 2 weeks of NK cell infusion as defined below (should correspond with admission for SCT):
- Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease related hemolysis, then < 3 x ULN)
- AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN
- Serum creatinine </= 2.0mg/dL
- O2 saturation: ≥90% on room air
- LVEF >40%. If there is no clinical evidence of a change in cardiovascular function from the time of pre-transplantation ECHO (per FACT standards should be performed within 6 weeks of stem cell infusion), then there is no need to repeat it. Otherwise, an ECHO will need to be repeated.
- Adult patients (age ≥ 18) eligible for and planned to undergo a standard-of-care reduced intensity conditioning (RIC) HLA-matched related or related haploidentical allogeneic stem cell transplant using PTCY-based GVHD prophylaxis. All eligibility criteria and workups for undergoing SOC allogeneic SCT for the recipient and donor will be based on institutional standards and SOPs.
- For patients with AML, the disease must meet criteria for CR/Cri according to 2017 ELN guidelines, or have 5-10% blasts at the time of the transplant and in the judgement of their primary BMT clinician and study PI to have no benefit from additional pre-transplant chemotherapy. For patients with MDS or MDS/MPN, the blast percentage on the bone marrow aspirate and biopsy must be less than 10%.
- The same related donor is available to provide a non-mobilized apheresis product after the stem-cell donation.
- ECOG performance status <= 2 (Karnofsky >= 60%, see Appendix C).
- Negative pregnancy test for women of childbearing age
- The effects of CIML NK cells combined with IL-2 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after IL-2 dose administration.
- No laboratory evidence of ongoing hemolysis in opinion of investigator
- Adequate organ function within 24 hours of NK cell infusion as defined below:
- Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then < 3 x ULN)
- AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN
- Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).
- No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)
- No evidence of ongoing hemolysis in opinion of investigator
Who cannot join
- Adult participants who are eligible for and who would be expected to have a greater benefit from myeloablative conditioning in their SOC allo HSCT as judged by their treating physician
- Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.
- Extramedullary leukemia involving sanctuary sites not readily accessible to immune surveillance, such as CNS or testis. Other sites of extramedullary relapse (e.g., leukemia cutis, granulocytic sarcoma) are acceptable.
- The planned use of sirolimus for GVHD prophylaxis would result in exclusion of the patient from the study. Consideration of the addition of sirolimus to the GVHD prophylaxis regimen within the first 100 days after transplant must be reviewed with the study PI.
- Prior history of allogeneic stem cell transplant other than SOC alloHSCT referred to in this study taking place 7 days prior to CIML NK infusion.
- Prior history of solid organ (allograft) transplantation
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- Prior history of allergic reactions to cellular products
- Uncontrolled concurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social illness that would limit compliance with study requirements.
- Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by Flu/Cy chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.
- HIV-positive patients are excluded due to the potential for interaction between antiretroviral therapy as well as the risk for lethal infection in the context of marrow-suppressive therapy.
- Patients with active and uncontrolled Hepatitis B or C are ineligible due to the high risk of treatment-related hepatotoxicity after cellular therapy.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1. History of other malignancy and have had complete remission of disease for at least 2 years; 2. Diagnosed and treated within the past 2 years for: nonmetastatic melanoma, surgically resected (not needing systemic chemotherapy) squamous cell carcinoma of skin and nonmetastatic prostate cancer not needing systemic chemotherapy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study. 3. Diagnosed with MGUS or smoldering myeloma, and/or treated for multiple myeloma or plasmacytoma as long as attainment of complete remission by IMWG criteria following therapy.
- Prior history of Grade 2 or higher hemolytic anemia (>/= 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.
- Systemic steroid therapy (oral or IV) on the day of NK cell infusion
- Uncontrolled concurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social illness that would limit compliance with study requirements.
- Participants who have had other investigational agents within 4 weeks prior to CIML NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 8 weeks prior, or those who have not recovered from adverse events due to agents administered more than 4 weeks prior. Therapy with BCR-ABL inhibitors must be stopped at least 2 weeks before CIML NK cell infusion and may not be resumed during the DLT period. The use of tocilizumab for cytokine release syndrome after stem cell infusion does not exclude patients, but the use of steroids for the treatment of CRS excludes patients if they are still on steroids by the day of planned NK cell infusion.
- Systemic steroid use of >10mg/day of prednisone equivalent is an exclusion criteria unless there is a plan for dose to be tapered below this limit within 4 weeks prior to NK cell infusion.
- Patients must be off systemic steroid therapy on the day of planned NK cell infusion.
- -The presence of donor-specific antibodies (DSAs) with mean fluorescence intensity (MFI) >1000 using a standard assay who do not receive a desensitization protocol prior to and during stem cell transplant, or else who do receive a desensitization protocol and have detectable DSAs +1 day after stem cell infusion.
- If inclusion/exclusion criteria are not met on planned day of CIML NK cell infusion, the NK cell infusion may be delayed for up to 48 hours to enable inclusion criteria to be met.
- However, patient may still receive CIML NK infusion if relevant parameters are reviewed and both PI and IND holder are in agreement with proceeding.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Roman Shapiro, MD, 617-632-3470, roman_shapiro@dfci.harvard.edu
Roman Shapiro, MD
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Roman Shapiro, MD, 617-632-3470, roman_shapiro@dfci.harvard.edu
Roman Shapiro, MD
About this study
Official title: Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I/Ib Clinical Trial
The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant.
Names of the study therapies involved in this study are:
- CIML NK cells intravenous infusion (cellular therapy)
- Subcutaneous Interleukin-2 (recombinant, human glycoprotein)
Read the detailed description
This is a phase I/Ib study of the pre-emptive treatment using related donor-derived cytokine induced memory-like (CIML) natural killer (NK) cells combined with Interleukin-2 (IL-2) for participants with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and MDS/myeloproliferative neoplasm (MDS/MPN) overlap syndrome at high risk for post-allogeneic stem cell transplant (SCT) relapse.
The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells as a treatment for AML, MDS or MDS and MPN overlap syndrome.
The research study procedures include screening for eligibility, intravenous infusion of CIML NK cells in the hospital, standard-of-care stem cell infusion, subcutaneous interleukin-2 (IL-2) infusions, x-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, bone marrow biopsies, echocardiograms, and electrocardiograms.
Participation in this research study is expected to last up to 3 years.
It is expected that up to 30 people will take part in this research study.
- Conditions
- Acute Myeloid Leukemia, Leukemia, Leukemia, Myeloid, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Myeloproliferative Disorders
- Being tested
- Cytokine Induced Memory-like Natural Killer Cells, Interleukin-2
- Keywords
- Acute Myeloid Leukemia, Leukemia, Leukemia, Myeloid, Myelodysplastic Syndrome, MDS and Myeloproliferative Neoplasm Overlap Syndrome
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Leukemia, Myeloid, Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine Induced Memory-like Natural Killer CellsBiological
Also called CIML NK cells
Allogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol.
Interleukin-2Biological
Also called Aldesleukin, Proleukin
Recombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous injection per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1/1b: CIML NK Cells + Interleukin-2 | Experimental | 5 eligible participants will be enrolled to determine the maximum tolerated dose (MTD) of CIML NK at starting dose level 0.
* Screening and baseline visit with assessments and bone marrow aspirate and biopsy.
* Day 0: Standard-of-care conditioning chemotherapy and stem cell infusion.
* Day 7: Predetermined dose of CIML NK cells 1x daily.
* Days 7, 9, 11, 13, 15: Predetermined dose of Interleukin-2 1x daily every other day (5 doses total).
* Dose limiting toxicity period for 6 weeks after infusion of CIML NK cells
If 0 or 1 dose limiting toxicity is observed at the dose level, then this dose will be the MTD and study will proceed to Phase 1b.
De-escalation to dose level -1 per protocol if ≥2 DLTs occur with dose Level 0.
In phase Ib, 10 additional participants will be enrolled at the maximum tolerated dose. Receives: Biological: Cytokine Induced Memory-like Natural Killer Cells; Biological: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT) [Phase 1]
All DLT was defined as an adverse event (AE) that is related to the CIML NK cell infusion combined with IL-2 in adult patients undergoing RIC HLA-matched related or haploidentical donor stem cell transplantation using PTCY-based GVHD prophylaxis. Toxicities are to be assessed according to the CTCAEv5 (Appendix C). Management and dose modifications associated with the above adverse events are outlined in protocol 6.
Measured: 6 weeks
Secondary outcomes (10)
Maximum Tolerated Dose (MTD) [Phase 1]
The MTD in the CIML NK cell infusion combined with IL-2 in adult patients undergoing RIC HLA-matched related or haploidentical donor stem cell transplantation using PTCY-based GVHD prophylaxis is determined by the number pf patients who experience a DLT. See previous primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than 2 out of 5 patient in each dose cohort experience a DLT. Dose-de-escalation will take place if MTD considered exceeded in each dose cohort.
Measured: 6 weeks
Complete Remission (CR/CRi) Rate (CRR)
The CRR is defined as the proportion of participants achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) based on criteria defined in protocol appendix H.
Measured: 100 days
Measurable Residual Disease (MRD) Rate
MRD rate is defined as the proportion pf participants achieving MRD using the validated NGS-based assay.
Measured: At 35 and 100 days
1-year Progression-Free Survival (PFS) Rate
1-year PFS is a probability estimated using progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last disease assessment.
Measured: 1 year
1-year Overall Survival (OS)
1-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive.
Measured: 1 year
6-month Graft-versus-host Disease (GVHD) and Relapse Free Survival (GRFS)
6-month GRFS is a probability estimated using the Kaplan-Meier method. GVHD-free relapse-free survival (GRFS) is defined as grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. GVHD assessment detail in protocol appendix G.
Measured: 6 months
12-month Graft-versus-host Disease (GVHD) and Relapse Free Survival (GRFS)
12-month GRFS is a probability estimated using the Kaplan-Meier method. GVHD-free relapse-free survival (GRFS) is defined as grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. GVHD assessment detail in protocol appendix G.
Measured: 12 months
100-day Acute GVHD Rates
Acute GVHD will be estimated in the competing risks framework treating death or relapse without developing GVHD as a competing event. GVHD assessment detail in protocol appendix G.
Measured: 100 days
6-month Acute GVHD Rates
Acute GVHD will be estimated in the competing risks framework treating death or relapse without developing GVHD as a competing event. GVHD assessment detail in protocol appendix G.
Measured: 6 months
12-month Chronic GVHD Rates
Chronic GVHD will be estimated in the competing risks framework treating death or relapse without developing GVHD as a competing event. GVHD assessment detail in protocol appendix G.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Jan 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Shapiro, MD, Dana-Farber Cancer Institute
- Investigators
- Roman Shapiro, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138587
- Sponsor's protocol ID
- 23-535
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I/Ib Clinical Trial
- ClinicalTrials.gov ID
- NCT06138587
- Acronym / sponsor ID
- 23-535
- Conditions
- Acute Myeloid Leukemia, Leukemia, Leukemia, Myeloid, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Myeloproliferative Disorders
- Keywords
- Acute Myeloid Leukemia, Leukemia, Leukemia, Myeloid, Myelodysplastic Syndrome, MDS and Myeloproliferative Neoplasm Overlap Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 18 Nov 2023 (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.
The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant.
Names of the study therapies involved in this study are:
- CIML NK cells intravenous infusion (cellular therapy)
- Subcutaneous Interleukin-2 (recombinant, human glycoprotein)
Detailed description
This is a phase I/Ib study of the pre-emptive treatment using related donor-derived cytokine induced memory-like (CIML) natural killer (NK) cells combined with Interleukin-2 (IL-2) for participants with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and MDS/myeloproliferative neoplasm (MDS/MPN) overlap syndrome at high risk for post-allogeneic stem cell transplant (SCT) relapse.
The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells as a treatment for AML, MDS or MDS and MPN overlap syndrome.
The research study procedures include screening for eligibility, intravenous infusion of CIML NK cells in the hospital, standard-of-care stem cell infusion, subcutaneous interleukin-2 (IL-2) infusions, x-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, bone marrow biopsies, echocardiograms, and electrocardiograms.
Participation in this research study is expected to last up to 3 years.
It is expected that up to 30 people will take part in this research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1/1b: CIML NK Cells + Interleukin-2 | Experimental | Biological: Cytokine Induced Memory-like Natural Killer Cells, Biological: Interleukin-25 eligible participants will be enrolled to determine the maximum tolerated dose (MTD) of CIML NK at starting dose level 0. * Screening and baseline visit with assessments and bone marrow aspirate and biopsy. * Day 0: Standard-of-care conditioning chemotherapy and stem cell infusion. * Day 7: Predetermined dose of CIML NK cells 1x daily. * Days 7, 9, 11, 13, 15: Predetermined dose of Interleukin-2 1x daily every other day (5 doses total). * Dose limiting toxicity period for 6 weeks after infusion of CIML NK cells If 0 or 1 dose limiting toxicity is observed at the dose level, then this dose will be the MTD and study will proceed to Phase 1b. De-escalation to dose level -1 per protocol if ≥2 DLTs occur with dose Level 0. In phase Ib, 10 additional participants will be enrolled at the maximum tolerated dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Histologically or cytologically confirmed diagnosis of AML, MDS, or MDS/MPN that is at high risk for post-transplant relapse and that has measurable disease prior to transplant. Patients at high risk for post-transplant relapse include:
- Adequate organ function within 2 weeks of NK cell infusion as defined below (should correspond with admission for SCT):
- Adult patients (age ≥ 18) eligible for and planned to undergo a standard-of-care reduced intensity conditioning (RIC) HLA-matched related or related haploidentical allogeneic stem cell transplant using PTCY-based GVHD prophylaxis. All eligibility criteria and workups for undergoing SOC allogeneic SCT for the recipient and donor will be based on institutional standards and SOPs.
- For patients with AML, the disease must meet criteria for CR/Cri according to 2017 ELN guidelines, or have 5-10% blasts at the time of the transplant and in the judgement of their primary BMT clinician and study PI to have no benefit from additional pre-transplant chemotherapy. For patients with MDS or MDS/MPN, the blast percentage on the bone marrow aspirate and biopsy must be less than 10%.
- The same related donor is available to provide a non-mobilized apheresis product after the stem-cell donation.
Key exclusion criteria (22 listed)
- Adult participants who are eligible for and who would be expected to have a greater benefit from myeloablative conditioning in their SOC allo HSCT as judged by their treating physician
- Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.
- Extramedullary leukemia involving sanctuary sites not readily accessible to immune surveillance, such as CNS or testis. Other sites of extramedullary relapse (e.g., leukemia cutis, granulocytic sarcoma) are acceptable.
- The planned use of sirolimus for GVHD prophylaxis would result in exclusion of the patient from the study. Consideration of the addition of sirolimus to the GVHD prophylaxis regimen within the first 100 days after transplant must be reviewed with the study PI.
- Prior history of allogeneic stem cell transplant other than SOC alloHSCT referred to in this study taking place 7 days prior to CIML NK infusion.
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 |
|---|---|---|
| Cytokine Induced Memory-like Natural Killer CellsAlso: CIML NK cellsAllogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol. | Biological | Phase 1/1b: CIML NK Cells + Interleukin-2 |
| Interleukin-2Also: Aldesleukin, ProleukinRecombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous injection per protocol. | Biological | Phase 1/1b: CIML NK Cells + Interleukin-2 |
Primary outcome
Dose Limiting Toxicity (DLT) [Phase 1]
Time frame: 6 weeks
All DLT was defined as an adverse event (AE) that is related to the CIML NK cell infusion combined with IL-2 in adult patients undergoing RIC HLA-matched related or haploidentical donor stem cell transplantation using PTCY-based GVHD prophylaxis. Toxicities are to be assessed according to the CTCAEv5 (Appendix C). Management and dose modifications associated with the above adverse events are outlined in protocol 6.
10 secondary outcomes
Maximum Tolerated Dose (MTD) [Phase 1]
Time frame: 6 weeks
Complete Remission (CR/CRi) Rate (CRR)
Time frame: 100 days
Measurable Residual Disease (MRD) Rate
Time frame: At 35 and 100 days
1-year Progression-Free Survival (PFS) Rate
Time frame: 1 year
1-year Overall Survival (OS)
Time frame: 1 year
6-month Graft-versus-host Disease (GVHD) and Relapse Free Survival (GRFS)
Time frame: 6 months
12-month Graft-versus-host Disease (GVHD) and Relapse Free Survival (GRFS)
Time frame: 12 months
100-day Acute GVHD Rates
Time frame: 100 days
6-month Acute GVHD Rates
Time frame: 6 months
12-month Chronic GVHD Rates
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Roman Shapiro, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cytokine Induced Memory-like Natural Killer Cells and Interleukin-2 in people with Acute Myeloid Leukemia and Leukemia, run by Dana-Farber Cancer Institute at 2 sites 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?
The sponsor lists 30 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roman Shapiro, MD (617-632-3470, roman_shapiro@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) [Phase 1] (time frame: 6 weeks). 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 17 Jun 2026.