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

Trial Status: Active

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).

Inclusion Criteria

  • 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

Pennsylvania

Philadelphia
Children's Hospital of Philadelphia
Status: ACTIVE
Contact: Nancy Jane Bunin
Phone: 215-590-2255

Trial Phase Phase II

Trial Type Treatment

Lead Organization
New York Medical College

  • Primary ID NYMC 580
  • Secondary IDs NCI-2019-05383
  • Clinicaltrials.gov ID NCT03266640