Pilot Study NYMC 579

NYMC 579

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

https://clinicaltrials.gov/ct2/show/NCT03266627?term=ADV+CTLs&recrs=a&draw=2&rank=1

Eligibility

1 Patients with Adenovirus (ADV) infections post allogeneic HSCT, post solid organ transplant or with primary immunodeficiencies and meets one of the following criteria:

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

and/or

– persistent clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis

AND/OR

– Medical intolerance to anti-viral therapies including: >grade 2 renal insufficiency secondary to cidofovir or other > grade 2 toxicities secondary to cidofovir

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

3. Age: 0.1 to 30.00 years

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

5. Patients must have 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. Patients cannot be enrolled in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s)

9. Patients cannot have known HIV infection

10. Patient with no known hypersensitivity to iron dextran

11. Patients with known human anti-mouse antibodies