Using specialized T-cells to treat adenovirus infections in patients with immune deficiencies

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 aims to administer adenovirus-specific cytotoxic T-lymphocytes to children, adolescents, and young adults suffering from refractory adenovirus infections following allogeneic hematopoietic stem cell transplantation or solid organ transplantation. The T-cells are manufactured using the Miltenyi CliniMACS Prodigy Cytokine Capture System and are intended for patients who have persistent adenovirus infections despite antiviral therapy. The study focuses on patients with primary immune deficiencies or those who have undergone solid organ transplants and are experiencing severe symptoms related to adenovirus.

Why it matters

Who can join: the full rules

1. Patients with Adenovirus infections post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with:

   * Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
   * clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis AND/OR
   * Medical intolerance to anti-viral therapies including:

     * grade 2 renal insufficiency secondary to cidofovir 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 years

   Females of childbearing potential with a negative urine pregnancy test
2. Donor Eligibility Related donor available with a T-cell response to the viral MACS® GMP PepTivator antigen(s) of adenovirus.

   a. Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor \> 1 HLA A, B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP PepTivator antigen(s) of adenovirus.

   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 adenovirus infection(s) 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

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Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Children's Hospital of Colorado
  Aurora, Colorado, United States Recruiting
• University of Colorado Denver
  Aurora, Colorado, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• Washington University
  St Louis, Missouri, 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

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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.