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Natural Killer Cell Therapy

Allogeneic CD56-positive CD3-negative Natural Killer Cells for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Led By Richard E Champlin

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses special cells from donors to treat patients with severe blood cancers. Medicine is used first to eliminate cancer cells and prepare the body. The donor cells help rebuild the patient's blood and immune system to fight cancer.

Eligible Conditions

Acute Myeloid Leukemia
Erythroleukemia
Myelodysplastic Syndrome
Chronic Myelogenous Leukemia
Aplastic Anemia
Acute Leukemia
Megakaryoblastic Leukemia
Chronic Myelomonocytic Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Who Experienced Dose-limiting Toxicities (DLT)

Secondary study objectives

Number of Participants With Grade 3 Toxicities

Overall Survival

Side effects data

From 2022 Phase 1 & 2 trial • 63 Patients • NCT01823198

100%

Mucositis

100%

Nausea

67%

Fluid overload

67%

Viral Infections

50%

Neutropenic fevers

50%

Skin GvHD

33%

Bacterial Infections

33%

Chronic ocular GvHD

33%

Chronic Skin GvHD

33%

Diarrhea

33%

Elevated transminitis

33%

Upper GI GvHD

17%

Chronic oral GvHD

17%

Chronic Liver GvHD

17%

Creatinine increased

17%

Elevated bilirubin

17%

Flu like syndrome

17%

Headache

17%

Pleural Effusion

17%

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Phase I: NK Cell Dose Level 1_10^6

Phase I: NK Cell Dose Level 2_10^7

Phase I: NK Cell Dose Level 3_ 3x10^7

Phase I: NK Cell Dose Level 4_ 10^8

Phase II: NK Cell Dose Level 3_3x10^7

Donors

Phase II: NK Cell Dose Level 4_ 10^8

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: Treatment (NK cells, PBSC transplant)Experimental Treatment8 Interventions

Patients receive fludarabine phosphate IV over 1 hour and busulfan IV over 3 hours on days -13 to -10. Patients then receive allogeneic CD56-positive CD3-negative natural killer cells IV over 1 hour on day -8. Patients also receive aldesleukin SC QD on days -8 to -4. Patients then undergo allogeneic PBSC transplant on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic CD56-positive CD3-negative Natural Killer Cells

2013

Completed Phase 2

~70

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1240