Actively Recruiting
Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus
Led by M.D. Anderson Cancer Center · Updated on 2025-11-18
100
Participants Needed
1
Research Sites
627 weeks
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
This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.
CONDITIONS
Official Title
Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 2 years or older, including English and non-English speakers
- Immunocompromised patients and/or patients with PML/JC virus encephalitis
- Patients with any type of malignancies, HIV/AIDS, history of solid organ transplant, or Merkel cell carcinoma with measurable disease
- Patients with microscopic hematuria or biopsy-proven BK nephritis and urine or blood PCR positive for BK virus and/or JC viral encephalitis or JC end-organ disease or polyomavirus
- Clinical condition allowing steroid tapering to less than 0.5 mg/kg/day of prednisone
- Patients currently receiving cidofovir, leflunomide, or other antiviral therapy without response
- Written informed consent or signed assent from patient, parent, or guardian; patients with cognitive impairments are eligible
- Negative pregnancy test for females of childbearing potential and willingness to use effective contraception during the study
- Patients may be enrolled on other IND studies at the investigator's discretion
- Patients may be re-enrolled if infection recurs and eligibility criteria are met
You will not qualify if you...
- Patients receiving prednisone at doses greater than 0.5 mg/kg/day at enrollment
- Patients who have received ATG within 14 days before enrollment
- Patients who have received donor lymphocyte infusion or Campath within 28 days before enrollment
- Patients with uncontrolled infections other than HIV/AIDS
- For bacterial infections, patients must be on definitive therapy with no signs of progressing infection for at least 72 hours before enrollment
- For fungal infections, patients must be on systemic antifungal therapy with no signs of progressing infection for at least 1 week before enrollment
- Patients with active acute graft-versus-host disease (GVHD) grades II-IV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Amanda L. Olson, MD
CONTACT
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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