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Cellular Therapy
NK Cell Therapy for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Roman Shapiro, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
De novo AML in CR1 AND MRD+ by Hematologics Inc. flow cytometry pretransplant (this would be on the most recent pre-transplant bone marrow)
De novo AML diagnosed at or after age 60, except CBF AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a cellular therapy and a glycoprotein can prevent relapse in AML, MDS, or MDS/MPN after stem cell transplant.
Who is the study for?
This trial is for adults aged 60 or older with newly diagnosed acute myeloid leukemia (AML), those in first complete remission but still have detectable disease, and patients with secondary AML, therapy-related MDS/AML, or certain types of myelodysplastic syndrome (MDS). Participants must have acceptable bilirubin levels unless due to Gilbert's syndrome or hemolysis.
What is being tested?
The study tests CIML NK cell infusions combined with Interleukin-2 injections to prevent cancer relapse in patients who've had a stem cell transplant for AML, MDS, or overlap syndromes. It aims to determine the safety and effectiveness of this approach.
What are the potential side effects?
Potential side effects may include reactions at the injection site from Interleukin-2, flu-like symptoms such as fever and chills, fatigue, nausea, and increased risk of infections due to immune system alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have acute myeloid leukemia in first complete remission and minimal residual disease detected.
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I was diagnosed with AML, not CBF AML, at age 60 or older.
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I have been diagnosed with MDS/MPN or CMML.
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My MDS shows more than 10% blasts before transplant.
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My condition is a blood cancer caused by previous cancer treatment.
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My condition is secondary acute myeloid leukemia.
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My condition is TP53-mutated MDS or AML.
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My condition is MDS with a specific chromosome change.
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I have had a bone marrow transplant for AML while in my second or later remission.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting Toxicity (DLT) [Phase 1]
Secondary study objectives
1-year Overall Survival (OS)
1-year Progression-Free Survival (PFS) Rate
100-day Acute GVHD Rates
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase 1/1b: CIML NK Cells + Interleukin-2Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-2
1994
Completed Phase 3
~690
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,145 Total Patients Enrolled
Roman Shapiro, MDPrincipal InvestigatorDana-Farber Cancer Institute
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