Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

Conditions:Infectious Disease, HIV / AIDS, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Age Range:Any - 30
Start Date:November 1, 2018
End Date:December 31, 2021
Contact:Mitchell S Cairo, MD

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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

CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine
Capture System will be administered in children, adolescents and young adults (CAYA) with
refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell
Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).

1. Patients with refractory CMV infection post allogeneic HSCT or with primary
immunodeficiencies with either

- Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of
appropriate anti-viral therapy AND/OR

- Medical intolerance to anti-viral therapies including:

- ANC < 500/mm2 secondary to ganciclovir

- 2 renal toxicity with foscarnet And/or

- known resistance to ganciclovir and/or foscarnet

Consent: Written informed consent given (by patient or legal representative) prior to any
study-related procedures.

Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) Age: 0.1 to 30.99 years
The first 3 patients entered and possibly the next 3 patients entered will be limited to
age 12.0 - 30.99 years. See section 9.3.4 for age eligibility in the first 6 patients.

There will be a temporary hold until 45 days after the 3rd patient and possibly the 6th
patient has received their CMV-CTLs, The study should be reopened for patients of all ages
(0.1-30.99 years). (See Section 9.3.4 for instructions) Females of childbearing potential
with a negative urine pregnancy test

Donor Eligibility Related donor available with a T-cell response to the CMV MACS® GMP
PepTivator antigen(s).

1. Original allogeneic donor if available, IgG positive for CMV and confirmatory testing
to respond to MACS GMP Peptivator CMV pp65.

2. Third Party Allogeneic Donor: If original donor is not available or does not have a
T-cell response: third party related allogeneic donor (family donor > 1 HLA A, B, DR
match to recipient) with IgG positive to CMV and/or a T-cell response to the CMV MACS®
GMP PepTivator .

AND Allogeneic donor disease screening is complete similar to hematopoietic stem cell
donors (Appendix 1).

AND Obtained informed consents by donor or donor legally authorized representative prior to
donor collection.

3 Patient exclusion criteria:

A patient meeting any of the following criteria is not eligible for the present study:

Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of CMV CTL infusion
Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CMV CTL
infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CMV
CTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal
antibodies within 30 days Patient with poor performance status determined by Karnofsky
(patients >16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitant
enrollment in another experimental clinical trial investigating the treatment of refractory
CMV infection.

Any medical condition which could compromise participation in the study according to the
investigator's assessment Known HIV infection Female patient of childbearing age who is
pregnant or breast-feeding or not willing to use an effective method of birth control
during study treatment.

Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the
protocol or unable to give informed consent.

Known human anti-mouse antibodies
We found this trial at
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Principal Investigator: Mitchell S. Cairo, MD
Phone: 914-594-2150
New York Medical College The College was founded in 1860 by a group of New...
Valhalla, NY
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Milwaukee, Wisconsin 53226
Phone: 414-955-4185
Milwaukee, WI
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Philadelphia, Pennsylvania
Phone: 215-590-2255
Philadelphia, PA
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