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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Awards & 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

~840

0 / 9Eligibility criteria met