Pilot Study of Expanded , Activated Haploidentical Natural Killer Cell Infusions for Sarcomas (NKEXPSARC)
Ewing Sarcoma, Rhabdomyosarcoma
About this trial
This is an interventional treatment trial for Ewing Sarcoma focused on measuring EWS, RMS
Eligibility Criteria
Inclusion Criteria:
A ) NK cell Recipient:
- Age 0 months to 80 years old.
Patients with metastatic, progressive or relapsed EWS, RMS after completing standard of care therapy who are at high risk of relapse even if they do not have any evidence of residual disease.
a) For patients without residual disease at the point of study entry, response to NK cells will be measured by their incidence of relapse as indicated by their 5-year event free survival. Only patients at high risk of relapse > 70% will be enrolled if there is no evidence of residual disease.
- Shortening fraction greater than or equal to 25%. Left ventricular ejection fraction (LVEF) greater than or equal to 40%
- Glomerular filtration rate greater than or equal to 60 ml/min/1.73 m2.
- Pulse oximetry greater than or equal to 92% on room air.
- Direct bilirubin less than or equal to 3.0 mg/dL (50 mmol/L).
- Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal.
- Aspartate transaminases (AST) is no more than 2 times the upper limit of normal.
- Karnofsky or Lansky performance score of greater than or equal to 50.
- Does not have a current pleural or pericardial effusion.
- Has a suitable adult family member donor available for NK cell donation.
- Has recovered from all acute NCI Common Terminology Criteria for Adverse Events (CTCAE) grade II-IV non-hematologic acute toxicities resulting from prior therapy per the judgment of the PI.
- At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.
- Is not receiving more than the equivalent of prednisone 10 mg daily.
- Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
- Not lactating.
B) NK cell Donor:
- First and second degree relative acceptable.
- 18 years of age or above.
- Not lactating.
- Greater than or equal to 3 of 6 HLA match to recipient.
- Meets eligibility and suitability criteria for hematopoietic cells donation as per institutional guidelines.
- Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
- HIV negative. Negative results must be within 60 days prior to enrolment.
Exclusion Criteria:
Failure to meet any of the inclusion criteria.
Sites / Locations
- National University HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Expanded, activated NK Cells(NKEXPSARC)
Intravenous infusion of expanded, activated NK Cells Donor cell will be expanded and activated in the cGMP compliant TECT lab for 10 to 12 days prior to infusion into the patient.