CIML NK Cells for Leukemia

Recruiting at 1 trial location

Overseen By Roman M. Shapiro, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.

Research Team

Susanne Baumeister, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults and children (12+) with certain relapsed myeloid diseases after stem cell transplant can join. They need a willing original donor for cell collection, no recent severe GVHD treatments, and must use birth control. Excluded are those with autoimmune disease, active infections like hepatitis or HIV, recent other cancer treatments outside of specific exceptions, or uncontrolled illnesses.

Inclusion Criteria

I haven't taken any systemic treatments for GVHD in the last 4 weeks.

I can take care of myself and do some daily activities.

My disease is still present after stem cell transplant and it's been over 2 months.

Exclusion Criteria

I have had severe graft-versus-host disease or it's currently active and needs treatment.

I do not have autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis, but Hashimoto's thyroiditis is okay.

I have received a solid organ transplant or a stem cell transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants receive Fludarabine and Cyclophosphamide as preparatory regimen

1 week

Daily visits for 3 days

Treatment

CIML NK cells are administered intravenously on day 0, followed by low-dose IL-2

6 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Regular visits up to 1 year

Treatment Details

Interventions

• CIML NK
• Cyclophosphamide
• Fludarabine

Trial Overview The trial is testing CIML NK cells combined with IL-2 in patients who have had a relapse of AML, MDS or MPN after stem cell transplantation. It will evaluate the safety and effectiveness of this treatment approach in both adult and pediatric patients.

Participant Groups

Group I: CIML NK Experimental Treatment 3 Interventions

* CIML NK cells will be administered intravenously on day 0. * Fludarabine will be administered as IV infusion once daily for 3 doses beginning on day -5. * Cyclophosphamide will be administered as IV infusion on days -5 and -4.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Rizwan Romee

Lead Sponsor

Trials

1

Recruited

50+

The Leukemia and Lymphoma Society

Collaborator

Trials

87

Recruited

26,200+