Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation

Conditions:Blood Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:January 30, 2017
End Date:February 28, 2022
Contact:Amanda Cashen, M.D.
Phone:(314) 454-8323

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A Phase II Study of Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation

This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia
free survival to 30% from <10% expected with the use of reduced intensity haplo-HCT in this
extremely high-risk patient cohort (based on the institutional experience using
non-myeloablative / reduced intensity conditioning in a similar patient cohort).

A formal safety evaluation will be done after every 6th patient enrolled and the trial will
be stopped if noted to have unusually higher engraftment failure (acute GVHD rates (>60% any
grades or >30% grade III/IV or ≥ 50% severe cGVHD) or engraftment failure rates (≥15%).

Recipient Inclusion Criteria:

- Refractory AML without complete remission (CR) after 2 or more cycles of induction
therapy (primary induction failure), or AML relapsed after obtaining a CR and failed
one cycle of re-induction therapy. Standard dose 10-day decitabine (20 mg/m2 daily IV
x 10 days) or 7-day azacitidine (75-100 mg/m2 daily SC/IV x 7 days) will be considered
as one cycle of induction therapy.

- At least 18 years of age

- Deemed to be not otherwise eligible for a non-myeloablative hematopoietic cell
transplant by the treating physician.

- Available HLA-haploidentical donor that meets the criteria in the protocol

- Patients with known CNS involvement with AML are eligible provided that they have been
treated and CSF is clear for at least 2 weeks prior to enrollment into the study. CNS
therapy (chemotherapy or radiation) should continue as medically indicated during the
study treatment.

- Karnofsky performance status > 60 %

- Adequate organ function as defined below:

- Total bilirubin < 2 mg/dl


- Creatinine within normal institutional limits OR creatinine clearance > 60
mL/min/1.73 m2 by Cockcroft-Gault Formula

- Oxygen saturation ≥90% on room air and adjusted DLCO of at least 40%

- Ejection fraction ≥40%

- Able to be off of corticosteroids (10 mg or less of prednisone or equivalent doses of
other systemic steroids are allowed) and any other immune suppressive medications
beginning on Day -3

- 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 and throughout the DLT evaluation

- Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).

Recipient Exclusion Criteria:

- Relapsed after allogeneic transplantation.

- Circulating blast count >30,000/uL by morphology or flow cytometry (cyto-reductive
therapies including leukapheresis or hydroxyurea are allowed).

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

- Presence of donor specific antibodies (DSA) with Mean Fluorescence Intensity (MFI) of
>2000 as assessed by the single antigen bead assay, < 6 weeks prior to starting
transplant conditioning

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

- New progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that
have not been evaluated with bronchoscopy. Infiltrates attributed to infection must be
stable/ improving after 1 week of appropriate therapy (4 weeks for presumed or proven
fungal infections)

- Known hypersensitivity to one or more of the study agents

- Received any investigational drugs within the 14 days prior to the first day of
transplant conditioning

- Pregnant and/or breastfeeding

Donor Inclusion Criteria:

- Related donor (sibling, offspring, or offspring of sibling)

- At least 18 years of age

- HLA-haploidentical donor/recipient match by at least Class I serologic typing at the
A&B locus.

- In general good health, and medically able to tolerate leukapheresis required for
harvesting the NK cells for this study.

- Ability to understand and willingness to sign an IRB approved written informed consent

Donor Exclusion Criteria:

- Positive for hepatitis, HTLV, or HIV on donor viral screen

- Pregnant and/or breastfeeding
We found this trial at
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Amanda Cashen, M.D.
Phone: 314-454-8323
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Saint Louis, MO
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