Using donor-derived T-cells to treat BK infections in patients with weakened immune systems
A Pilot Study in the Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients
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.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Month to 79 Years |
| Sex | All |
| Sponsor | New York Medical College Academic / other |
| Drugs / interventions | Alemtuzumab, prednisone |
| Locations | 7 sites (San Francisco, California and 6 other locations) |
| Trial ID | NCT04197596 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of BK-specific cytotoxic T-cells (CTLs) in reducing viral load in children, adolescents, and young adults suffering from refractory BK infections following allogeneic hematopoietic stem cell transplantation or those with primary immunodeficiencies. The CTLs are manufactured using the Miltenyi CliniMACS Prodigy Cytokine Capture System. Participants will be monitored for changes in viral load after receiving the CTL treatment, which aims to provide a targeted approach to managing persistent BK infections.
Who should consider this trial
Good fit: Ideal candidates include children, adolescents, and young adults with refractory BK infections post-transplant or with primary immunodeficiencies who have not responded to standard antiviral therapies.
Not a fit: Patients with acute graft-versus-host disease greater than grade 2 or those receiving high-dose steroids may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with refractory BK infections, potentially leading to better recovery and quality of life.
How similar studies have performed: Other studies using similar approaches with T-cell therapies have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: .1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either * Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR * Medical intolerance to anti-viral therapies including: * 2 renal toxicity with cidofovir or other \> grade 2 toxicities secondary to cidofovir And/or * known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures. 1.3 Performance Status \> 30% (Lansky \< 16 yrs and Karnofsky \> 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test Exclusion: 1. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK CTL infusion 2. Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion 3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion 4. Thymoglobulin (ATG) or Alemtuzumab within 30 days 5. Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% 6. Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection. 7. Any medical condition which could compromise participation in the study according to the investigator's assessment 8. Known HIV infection 9. 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. 10. Known hypersensitivity to iron dextran 11. Patients unwilling or unable to comply with the protocol or unable to give informed consent. 12. Known human anti-mouse antibodies
Where this trial is running
San Francisco, California and 6 other locations
- 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 — Vallhala, New York, United States (Recruiting)
- Nationwide Children's Hosptial — Columbus, Ohio, United States (Recruiting)
- Children's Hospital of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Mitchell S Cairo, MD — New York Medical College
- Study coordinator: Mitchell S Cairo, MD
- Email: mitchell_cairo@nymc.edu
- Phone: 9145942150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.