Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation.
Amanda Olson, Ruitao Lin, David Marin...
https://pubmed.ncbi.nlm.nih.gov/33929874Actively Recruiting
Phase 2
All Genders
ID02479698
Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK and JC Virus Infection
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well donor cytotoxic T lymphocytes (CTLs) work in treating patients with malignancies who have BK and/or JC virus infections. This phase II study aims to assess the effectiveness, safety, and feasibility of giving BK-specific CTL lines that are closely matched to the patient's human leukocyte antigen (HLA) to fight these viral infections. The study also examines how long the infused CTLs persist in the body of patients with malignancies, HIV/AIDS, or a history of solid organ transplant who have BK and JC infections. Patients receive intravenous infusions of allogeneic BK-specific cytotoxic T lymphocytes over 30 minutes. After the first infusion, those who show partial response, stable disease, or progressive disease may receive up to 19 additional infusions, each given at least two weeks apart, if they meet the criteria for further treatment. The treatment period is followed by regular monitoring and assessments. Participants undergo evaluations including response to treatment, monitoring for acute graft-versus-host disease within 28 days after the last CTL dose, and tracking of adverse events up to 100 days. They are followed up periodically for 12 months after completing treatment to assess overall survival and kidney function. The study involves laboratory biomarker analysis as part of correlative studies to better understand treatment effects and patient outcomes.
CONDITIONS
Brief Title
Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 2 years or older, including English and non-English speakers
- Immunocompromised patients; or non-immunocompromised patients with JC virus encephalitis; or patients with any malignancy, HIV/AIDS, history of solid organ transplant, or Merkel cell tumor with measurable disease
- Patients with microscopic hematuria or biopsy-proven BK nephritis and positive BK virus or JC viral infection confirmed by PCR or clinical diagnosis
- Clinical status allowing tapering of steroids to less than 0.5 mg/kg/day prednisone
- Patients currently receiving certain antiviral treatments without response are eligible
- Written informed consent or assent from patient, parent, or guardian; cognitive impairments allowed
- Negative pregnancy test for females of childbearing potential and willingness to use contraception
- Patients may be enrolled on other IND studies or re-enrolled if infection recurs and criteria are met
You will not qualify if you...
- Patients receiving prednisone above 0.5 mg/kg/day at enrollment or recent treatment with ATG, donor lymphocyte infusion, or Campath
- Patients with uncontrolled infections other than HIV/AIDS, unless infections are stable under therapy
- Patients with active acute graft-versus-host disease grades II-IV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to approximately 38 weeks depending on number of infusions
Participants receive allogeneic BK-specific cytotoxic T-lymphocytes intravenously over 30 minutes. If eligible, participants may receive up to 19 additional infusions spaced at least 2 weeks apart depending on response and eligibility for subsequent therapy.
1 initial infusion visit and up to 19 additional infusion visits every 2 weeks or more apart
Follow-up
Duration - Up to 12 months
Participants are followed up periodically after completion of study treatment to monitor overall survival, kidney function, and safety for up to 12 months.
Periodic follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
A
Amanda L. Olson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Allogeneic BK Virus-Specific T Cells for Progressive Multifocal Leukoencephalopathy.
Muharrem Muftuoglu, Amanda Olson, David Marin...
https://pubmed.ncbi.nlm.nih.gov/30304652