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Cell Therapy

Memory-like NK Cell Therapy for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Led By Amanda Cashen, 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

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)

Available original donor (same donor as used for the initial stem cell transplant) that is willing and eligible for non-mobilized collection

Must not have

Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities

Uncontrolled bacterial or viral infections, or known HIV, Hepatitis B, or Hepatitis C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post ciml nk cell infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether combining CIML NK cells with DLI will help patients with leukemia who have relapsed after allo-HCT.

Who is the study for?

This trial is for adults who have relapsed Acute Myeloid Leukemia after a stem cell transplant from a matched donor. They must be in good health, with normal organ function and no active infections or uncontrolled heart conditions. Pregnant women or those on systemic steroids/high blast counts are excluded.

What is being tested?

The study tests combining Cytokine Induced Memory-like Natural Killer (CIML NK) cells with Donor Lymphocyte Infusion (DLI) to improve treatment outcomes in relapsed AML patients post-transplant. It aims to enhance graft versus leukemia effects without excessive Graft versus Host Disease.

What are the potential side effects?

Potential side effects may include reactions related to immune activation such as fever, fatigue, and risk of infection. There's also the possibility of developing mild to severe Graft versus Host Disease due to immune system interactions.

Eligibility Criteria

Inclusion Criteria

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

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My original stem cell donor is available and willing to donate again without mobilization.

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I can care for myself but may not be able to do active work.

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My AML has returned after a bone marrow transplant from a matched donor.

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I am 18 years old or older.

Exclusion Criteria

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

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I do not have severe heart issues like uncontrolled chest pain or irregular heartbeats.

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I do not have uncontrolled infections or known HIV, Hepatitis B, or C.

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I have new or worsening lung infections.

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I am currently receiving treatment for Graft vs. Host Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post ciml nk cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post ciml nk cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post ciml nk cell infusion 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 regimen defined as the number of participants who are successfully infused with T cell DLT and CIML NK cells (Pilot Pediatric/Young Adult Cohort)

Safety of administering CIML NK cells plus T cell DLT as measured by prolonged neutropenia (Phase 2 Adult Cohort)

Safety of administering CIML NK cells plus T cell DLT as measured by prolonged neutropenia (Pilot Pediatric/Young Adult Cohort)

+4 more

Secondary study objectives

Complete remission rate (CR/CRi) (Phase 2 Adult Cohort)

Complete remission rate (CR/CRi) (Pilot Pediatric/Young Adult Cohort)

Incidence and severity of acute GVHD rates (Phase 2 Adult Cohort)

+7 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: CIML NK cell after T cell DLT (Pilot Pediatric/Young Adult Cohort)Experimental Treatment2 Interventions

* The recipient will receive standard of care salvage chemotherapy consisting of fludarabine (or cladribine if shortage), cytarabine, and G-CSF (FLAG) to be started 2 to 4 weeks prior to the CIML NK cell infusion. 5-day decitabine is an acceptable alternative for FLAG, and another standard of care salvage chemotherapy regimen, if clinically appropriate and approved by the study PI, may be used. * The donor will undergo non-mobilized leukapheresis on Day -2 or -1. Standard of care DLI (1 x 10\^6 CD3+ cells/kg) will be given fresh on day -1. * 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.

Group II: CIML NK cell after T cell DLT (Phase 2 Adult Cohort)Experimental Treatment2 Interventions

* The recipient will receive lymphodepleting chemotherapy with fludarabine (or cladribine if shortage) and cyclophosphamide beginning on day -7. * The donor will undergo non-mobilized leukapheresis on Day -2 or -1. T cell dose per standard of care institutional practices and physician discretion will be given frozen for administration on day 30. * 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. The date of the second NK cell infusion will be considered a second Day 0.

0 / 9Eligibility criteria met