A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies

A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00569179

Enrollment

Registered

2007-12-07

Start date

2007-08-31

Completion date

2010-12-31

Last updated

2015-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoid, Leukemia, Myelogenous, Chronic, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

Keywords

Myeloid Malignancies, Bone Marrow Transplant, AML, ALL, MDS, CML

Brief summary

The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.

Interventions

DEVICECliniMACS CD34 Reagent System

Alloreactive NK cells will be purified by a two-step immunomagnetic selection (CD3 depletion followed by CD56 selection) using the CliniMACS device.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients must have histologically documented AML, ALL, MDS, CML, * Identification of haploidentical donor * LVEF \> 45% corrected * DLCO \> 50% predicted * Serum Creatinine \<= 2 mg/dL * Bilirubin \< 2 x ULN * AST, ALT \< 2 x ULN * Age ≤ 65 years * Performance Status 0-1

Exclusion criteria

* Patients relapsing \<6 months after autologous SCT are not eligible. * Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection * No HIV disease * Non-pregnant and non-nursing

Design outcomes

Primary

Measure	Time frame
Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies.	through Day 128

Secondary

Measure	Time frame
Assess toxicity associated with the infusion of alloreactive NK cells	through Day 128
Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells.	through Day 128
Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses.	through Day 128
Describe the frequency and type of infections occurring within the first year following transplantation.	through Day 128
Describe immune reconstitution following transplantation.	through Day 128

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026