BridgeMD
New treatment option for Viral Infection
Official title Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
ClinicalTrials.gov ID: NCT04197596
What this study is testing
What is BK CTL?
BK CTL is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for viral infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 79
You may be able to join if
- .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...
- 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...
See the full eligibility 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) 1.4 Age: 0.1 to...
- Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK CTL infusion
- Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
- Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
- Thymoglobulin (ATG) or Alemtuzumab within 30 days
- 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 BK 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Vallhala, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Vallhala, New York, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.