Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
S
Scott Goebel, MD
Primary Investigator
Enrolling By Invitation
1-30 years
All
Phase
2
20 participants needed
2 Locations
Overview
CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine
Capture System will be administered in children, adolescents and young adults (CAYA) withy cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell
Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ.
Funding Source: FDA OOPD
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Cytomegalovirus Infections, Primary Immune Deficiency Disorder
-
Age: Between 1 Month - 30 Years
-
Gender: All
- Patients with refractory CMV infection post allogeneic HSCT, with primary
immunodeficiencies or post solid organ transplant with either
- Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks ofviral 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 79.99 years 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)
.
a. 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
Updated on
15 May 2024.
Study ID: NYMC 580, PHO-NYMC-580CMV, 12861
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