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Stem Cell Transplant

Memory-like NK Cells after Haploidentical Transplant for AML (ABCD-NK Trial)

Saint Louis, MO

Phase 1 & 2

Recruiting

Led By Thomas M Pfeiffer, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

High risk acute myeloid leukemia (AML) in either complete remission (CR) or morphological leukemia free state (MLFS)

De novo AML in CR1 with specific high-risk features

Must not have

Active non-hematologic malignancy

Active CNS or extramedullary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from transplant through month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new stem cell transplant method to help children and young adults with AML. It adds a drug and modified donor cells to a half-matched transplant to improve its effectiveness.

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Who is the study for?

This trial is for children and young adults (≤30 years) with high-risk acute myeloid leukemia, either in remission or a specific free state. They must have good organ function, agree to use contraception, and have a half-matched family donor. It's not for those with active GvHD, other cancers, CNS disease, significant allergies to similar treatments, or who are pregnant/breastfeeding.Check my eligibility

What is being tested?

The study tests the effectiveness of stem cell transplants from half-matched donors followed by an infusion of memory-like natural killer cells in patients with AML. The process includes removing certain immune cells from the graft to reduce complications and administering interleukin-2 after transplant.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune cell infusion such as fever or chills; organ inflammation due to immune response; increased risk of infections; and typical stem cell transplant-related side effects like mouth sores or low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My AML is high risk but currently in remission or free of leukemia signs.

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My AML is in its first complete remission and has high-risk features.

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My AML developed from a previous condition called MDS.

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I had a bone marrow transplant and am currently in remission.

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I am 30 years old or younger.

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I can do most activities but need help with a few.

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I have a family member who is a genetic match for a donation.

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My acute myeloid leukemia is in its second or later remission.

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My AML, caused by previous therapy, is in its first complete remission.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active cancer that is not related to blood.

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My cancer has spread to my brain or outside the bone marrow.

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I cannot stop taking medication that affects ML NK cell activity.

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I have Fanconi Anemia or Down Syndrome.

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I do not have any unmanaged ongoing illnesses.

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I currently have GvHD or have recently been on immunosuppressants.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from transplant through month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from transplant through month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from transplant through month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of manufacturing and administering donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplant

Safety of patients being administered donor-derived ML NK cells following TCR alpha beta depleted haploidentical cell transplant

Secondary study objectives

Analysis of immune reconstitution

Development of acute graft versus host disease (aGvHD)

Development of chronic graft versus host disease (cGvHD)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Recipient, Reduced Intensity Conditioning (RIC)Experimental Treatment8 Interventions

Patients will undergo Reduced Intensity Conditioning (RIC) consisting of rabbit antithymocyte globulin (rATG), Fludarabine, Melphalan, and Thiotepa. All agents are administered intravenously. rATG is administered from days -9 to -7. Fludarabine is administered from day -8 to day -5, followed by Thiotepa on day -4 and Melphalan on days -3 and -2. On Day 0, patients will undergo infusion of the ex vivo TCRαβ/CD19+ depleted haploidentical HPC graft. On Day +7, patients will undergo infusion of the memory-like NK (ML NK) cells, followed by IL-2 subcutaneously starting 4 hours after the ML NK infusion. IL-2 will continue every other day through Day +19 for a maximum of 7 doses.

Group II: Recipient, Myeloablative Conditioning (MAC)Experimental Treatment8 Interventions

Patients will undergo Myeloablative Conditioning (MAC) consisting of rabbit antithymocyte globulin (rATG), Busulfan, Fludarabine, and Thiotepa. All agents are administered intravenously. rATG is administered from days -9 to -7, followed by Busulfan and Fludarabine from days -6 to -3, and Thiotepa on day -2. On Day 0, patients will undergo infusion of the ex vivo TCRαβ/CD19+ depleted haploidentical HPC graft. On Day +7, patients will undergo infusion of the memory-like NK (ML NK) cells, followed by IL-2 subcutaneously 4 hours after the ML NK infusion. IL-2 will continue every other day through Day +19 for a maximum of 7 doses.

Group III: DonorExperimental Treatment2 Interventions

Donors will undergo 2 leukapheresis collections. First, patients will be mobilized using G-CSF for 5 days followed by leukapheresis on the day prior to planned stem cell transplant. The second collection will occur on Day +6 after stem cell transplant and will be non-mobilized.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CliniMACS

2005

Completed Phase 3

~770

Busulfan

2008

Completed Phase 4

~1710