Pilot Study NYMC 581

NYMC 581

A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection with Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients.

https://clinicaltrials.gov/ct2/show/NCT03266653?term=EBV+CTLs&recrs=a&draw=2&rank=9

Eligibility

1. Patients with Epstein-Barr virus infections post allogeneic HSCT, post solid organ transplant or with primary immunodeficiencies with any one of the following criteria:

– Increasing EBV RT-PCR DNA (by 1 log) after 7 days or persistent quantitative EBV RT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy

and/or

-progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly

AND/OR

– Medical intolerance to anti-viral therapies including intolerance to rituximab

2. Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs)

3. Age: 0.1 to 30.99 years

4. Females of childbearing potential with a negative urine pregnancy test at study entry only.

5. Patients with acute GVHD > grade 2 or severe chronic GVHD at the time of CTL infusion

5.3.2. Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CTL infusion

5. Less than grade 2 acute GHVD and/or no chronic GVHD at the time of CTL infusion

6. Patient receiving steroids must be <0.5 mg/kg prednisone equivalent at the time of CTL infusion

7. Patients are at least 4 weeks post DLI infusion

8. Patient cannot be enrolled in another experimental clinical trial investigating the treatment of refractory EBV infection.

9. Patient does not have known HIV infection

10. Patient does not have known hypersensitivity to iron dextran

11. Patient does not have known human anti-mouse antibodies