Using EBV-specific T-cells to treat difficult Epstein-Barr virus infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on administering Epstein-Barr virus (EBV) specific cytotoxic T-lymphocytes (CTLs) to children, adolescents, and young adults who have refractory EBV infections following allogeneic hematopoietic stem cell transplantation or solid organ transplantation. The CTLs are manufactured using the Miltenyi CliniMACS Prodigy Cytokine Capture System and aim to target persistent EBV infections that do not respond to standard antiviral therapies. Participants will be monitored for clinical improvements and changes in EBV viral load following treatment.

Why it matters

Who can join: the full rules

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.

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

Where it's running

• Children's Hosptial Los Angeles
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• New York Medical College
  Valhalla, New York, United States Recruiting
• Nationwide Children's Hosptial
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Mitchell Cairo, MD — New York Medical College
• Study coordinator: Mitchell Cairo, MD
• Email: mitchell_cairo@nymc.edu
• Phone: 914-594-2150

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Partially HLA-matched virus-specific T-cell therapy for adenovirus, CMV, or EBV in immunocompromised patients

  This will try partially matched virus-specific T cells to treat adenovirus, CMV, or EBV infections in people whose immune systems are weakened after stem-cell or organ transplants or other immunodeficiencies.

  Recruiting at 2 sites Phase 1/2 Stanford University · Palo Alto, California and 2 other locations · NCT06909110

• Treatment with STAR0602 for advanced solid tumors

  This study is testing a new treatment called STAR0602 to see if it can help people with advanced solid tumors by looking at how safe it is and how well it works.

  Recruiting at 16 sites Phase 1/2 Marengo Therapeutics, Inc. · Sacramento, California and 18 other locations · NCT05592626

• Treatment of viral infections using rapidly generated T cells

  This study is testing a new treatment using specially made T cells to help patients with weakened immune systems who are struggling with serious viral infections like Epstein-Barr or cytomegalovirus.

  Recruiting Phase 1 Columbia University · New York, New York · NCT05183490

• Using Rituximab to prevent Epstein-Barr Virus infection in kidney transplant patients

  This study is testing if a single dose of Rituximab can help prevent Epstein-Barr Virus infection in kidney transplant patients who are at risk for complications.

  Recruiting Phase 4 University Hospital, Strasbourg, France · Strasbourg · NCT04989491

• Reduced intensity bone marrow transplant for immune and bone marrow disorders

  This study is testing a gentler type of bone marrow transplant to see if it can help people with immune and bone marrow disorders recover better and live longer.

  Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT04232085

• Using donor-derived T-cells to treat BK infections in patients with weakened immune systems

  This study is testing if special immune cells made from donors can help children and young adults with weak immune systems get rid of stubborn BK infections after a stem cell transplant.

  Recruiting at 7 sites Phase 1/2 New York Medical College · San Francisco, California and 6 other locations · NCT04197596

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.