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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03266653
Other study ID # NYMC 581
Secondary ID FD006363
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 7, 2020
Est. completion date December 31, 2025

Study information

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

Clinical Trial Summary

Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV 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, 2025
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 79 Years
Eligibility 1. Patients with Epstein-Barr virus infections post allogeneic HSCT, primary immunodeficiencies or post solid organ transplant with: - Increasing or persistent quantitative EBV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or - progressive clinical symptoms attributable to EBV, including biopsy proven colitis, lymphadenopathy, hepatomegaly, splenomegaly AND/OR - Medical intolerance to anti-viral therapies including: - intolerance to rituximab 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 2 Donor Eligibility 5.2.1 Related donor available with a T-cell response to the EBV MACSĀ® GMP PepTivator antigen(s) causing the therapy-refractory EBV infection. a. Third Party Related 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 EBV and/or a T-cell response at least to the viral MACSĀ® GMP PepTivator EBV Select (containing among other antigens, NA-1, LMP2A and BZLF-1). 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 CTL infusion Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients =16 years) score =30% Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory EBV 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
cytotoxic t-lymphocytes
EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs.

Locations

Country Name City State
United States Johns Hopkins Baltimore Maryland
United States Nationwide Children's Hosptial Columbus Ohio
United States Children's Hosptial 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 (8)

Lead Sponsor Collaborator
New York Medical College Children's Hospital of Philadelphia, Indiana University, Medical College of Wisconsin, Nationwide Children's Hospital, University of California, Los Angeles, 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 related to the infusion of EBV CTLs Patients will be followed for 12 weeks after each infusion
Primary Incidence of Response to Treatment [Efficacy] Patients will be followed for improvement in viral infection by monitoring EBV PCR weekly for response to treatment with CTLs Patients will be followed for 12 weeks after each infusion
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