NCT04197596 Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
| NCT ID | NCT04197596 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | New York Medical College |
| Condition | Viral Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2020-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
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
Contact & Investigator
Mitchell S Cairo, MD
PRINCIPAL INVESTIGATOR
New York Medical College
Frequently Asked Questions
Who can join the NCT04197596 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 79 Years, studying Viral Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04197596 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04197596 currently recruiting?
Yes, NCT04197596 is actively recruiting participants. Contact the research team at mitchell_cairo@nymc.edu for enrollment information.
Where is the NCT04197596 trial being conducted?
This trial is being conducted at San Francisco, United States, Baltimore, United States, St Louis, United States, Vallhala, United States and 3 additional locations.
Who is sponsoring the NCT04197596 clinical trial?
NCT04197596 is sponsored by New York Medical College. The principal investigator is Mitchell S Cairo, MD at New York Medical College. The trial plans to enroll 40 participants.