Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

Launched by NEW YORK MEDICAL COLLEGE · Dec 11, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients, particularly children, adolescents, and young adults, who have a persistent BK virus infection after receiving a stem cell transplant or those with certain immune system disorders. The treatment involves using special cells, called cytotoxic T-cells, which are designed to target and reduce the BK virus in the body. The goal is to determine if these cells are safe and effective in helping patients who have not responded to traditional antiviral medications.

To be eligible for the trial, patients must be between the ages of 0 and 79 and have a BK infection that has not improved even after receiving appropriate antiviral treatment for at least two weeks. Patients should also have a certain level of physical well-being, as measured by specific scoring systems. However, there are some exclusions, such as those with severe complications from transplantation or other serious health issues. Participants can expect to receive the specially manufactured T-cells and will be closely monitored throughout the study to assess their response to the treatment and any potential side effects. Overall, this trial aims to provide new hope for patients struggling with difficult-to-treat BK infections.

Gender

ALL

Eligibility 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