Pilot Study NYMC 580

NYMC 580

A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections with Related Donor CMV Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients

https://clinicaltrials.gov/ct2/show/NCT03266640?term=CMV+CTLs&recrs=a&draw=2&rank=2


Eligibility

1. Patients with refractory CMV infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with any of the following criteria:

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

AND/OR

– Medical intolerance to anti-viral therapies including:

– ANC < 500/mm2 secondary to ganciclovir and or >2 renal toxicity with foscarnet or other > grade 2 toxicities secondary to foscarnate

And/or

-known resistance to ganciclovir and/or foscarnet

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 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, Patient must not have received Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal antibodies within 30 days

9. Patient does not have known CMV retinitis

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

11. Patient does not have known HIV infection

12. Patient does not have known hypersensitivity to iron dextran

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