← Back to Search

Natural Killer Cell Therapy

Allogeneic CD56-positive CD3-negative Natural Killer Cells for Chronic Myelogenous 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

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
  • Chronic Myelogenous Leukemia
  • Acute Myeloid Leukemia
  • Aplastic Anemia
  • Acute Erythroid Leukemia
  • Myelodysplastic Syndrome
  • Megakaryoblastic Leukemia
  • Chronic Myelomonocytic Leukemia

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experienced Dose-limiting Toxicities (DLT)
Secondary outcome measures
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%
0%
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

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
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Aldesleukin
2012
Completed Phase 4
~1620
Busulfan
2008
Completed Phase 3
~930
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,216 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,338 Total Patients Enrolled
Richard E ChamplinPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
~5 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top