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

Launched by NEW YORK MEDICAL COLLEGE · Aug 28, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for children, adolescents, and young adults who are struggling with a persistent cytomegalovirus (CMV) infection after receiving a stem cell transplant or an organ transplant. The treatment involves giving patients specially made immune cells called cytotoxic T-lymphocytes (CTLs) that are designed to target and fight the CMV virus. This trial is important for patients who have not responded well to standard antiviral medications, which may include those experiencing side effects or those whose infections continue despite treatment.

To be eligible for the trial, participants should be between 0.1 and 79.99 years old and have a CMV infection that is not responding to current treatments. They must also have a related donor available who has a specific immune response to the CMV virus. Participants will need to provide written consent before starting any study-related procedures. If you or someone you know is considering this trial, it's a chance to receive an innovative treatment that could help manage a challenging infection.

Gender

ALL

Eligibility criteria

• • 1. 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 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 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 CMV retinitis, meningitis, encephalitis, and/or cerebritis