What this study is
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
What's being tested
- cytotoxic t-lymphocytes
Intervention · DRUG
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.
Study details
- Official title
- 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
- Sponsor
- New York Medical College
- Conditions
- Epstein-Barr Virus Infections · Primary Immune Deficiency Disorder
- Enrolling
- 20 people
- Starts
- 2020-07-07
- Est. completion
- 2027-12-31
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Month – 79 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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. 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (8)
8 openChildren's Hosptial Los Angeles
Los Angeles, California, United States
- Neena Kapoor, MD · Contactnkapoor@chla.usc.edu
RecruitingUniversity of California San Francisco
San Francisco, California, United States
- Julia Chu, MD · ContactJulia.Chu2@ucsf.edu
RecruitingJohns Hopkins
Baltimore, Maryland, United States
- Kenneth Cooke, MD · Contact
RecruitingWashington University
St Louis, Missouri, United States
- Shalini Shenoy, MD · Contactshalinishenoy@wustl.edu
RecruitingNew York Medical College
Valhalla, New York, United States
- Mitchell S Cairo, MD · Contact914-594-2150mitchell_cairo@nymc.edu
- Mitchell S. Cairo, MD · Principal investigator
RecruitingNationwide Children's Hosptial
Columbus, Ohio, United States
- Dean Lee, MD, PhD · Contact614-722-3550Dean.Lee@nationwidechildrens.org
RecruitingChildren's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
- Nancy Bunin, MD · Contact215-590-2255buninn@email.chop.edu
RecruitingMedical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
- Julie A Talano, MD · Contact414-955-4185jtalano@mcw.edu
- Meredith Beversdorf, RN · Contact(414) 266-5891mbeversdorf@mcw.edu
Recruiting
Study team
Sponsor
New York Medical College
Study ID NYMC 581
Principal investigator
Mitchell Cairo, MD
New York Medical College
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.