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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03266640
Other study ID # NYMC 580
Secondary ID FD006363
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 1, 2018
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source New York Medical College
Contact Mitchell S Cairo, MD
Phone 914-594-2150
Email mitchell_cairo@nymc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 79 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
viral specific cytotoxic t-lymphocytes
CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.

Locations

Country Name City State
United States Johns Hopkins Baltimore Maryland
United States Nationwide Children's Hosptial Columbus Ohio
United States Indiana University Indianapolis Indiana
United States Children's Hospital Los Angeles Los Angeles California
United States Medical College of Wisconsin/Children's Hospital of Wisconsin Milwaukee Wisconsin
United States Children's Hospital of Pennsylvania Philadelphia Pennsylvania
United States Washington University Saint Louis Missouri
United States University of California San Francisco San Francisco California
United States New York Medical College Valhalla New York

Sponsors (9)

Lead Sponsor Collaborator
New York Medical College Children's Hospital Los Angeles, Children's Hospital of Philadelphia, Indiana University, Johns Hopkins University, Medical College of Wisconsin, Nationwide Children's Hospital, University of California, San Francisco, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Patients will be monitored for adverse events following the administration of CMV CTLs Patients will be followed for 12 weeks after each infusion
Primary Incidence of Response to Treatment Patients will be followed for improvement in viral infection by monitoring CMV PCR weekly for response to treatment with CTLs Patients will be followed 12 weeks after each infusion
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