A Pilot Study in the Treatment of Refractory Epstein-Barr Virus (EBV) Infection with Related Donor EBV Cytotoxic T-Lymphocytes in Children, Adolescents and Young Adult Recipients - NYMC 581

S
Scott Goebel, MD

Primary Investigator

Enrolling By Invitation
1 month - 79 years
All
Phase 2
20 participants needed
2 Locations

Brief description of study

What is the purpose of this study?
Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured withhe Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children,dolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • All patients given identical treatment with CTLs for refractory EBV.
  • Patients with refractory EBV will get one dose of EBV specific CTLs. 
  • If they don't show a response based on EBV PCRs, patients may get up to another 4 doses of EBV-CTLs (5 doses maximum)

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Epstein-Barr Virus Infections, Primary Immune Deficiency Disorder, Riley
  • Age: 1 month - 79 years
  • Gender: All

Inclusion criteria
  • 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 MACS® 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 MACS® 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.

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

Updated on 13 Sep 2024. Study ID: NYMC 581, PHO-NYMC-581EBV, 12864
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