Cytotoxic T Lymphocytes for Virus-Related Cancer
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that patients must be able to reduce steroids to less than 0.5 mg/kg/day of prednisone. If you are on antiviral therapy like cidofovir or leflunomide without response, you can still participate.
What data supports the effectiveness of the treatment Allogeneic BK-specific Cytotoxic T-lymphocytes for virus-related cancer?
Is the treatment with cytotoxic T lymphocytes for virus-related cancer generally safe in humans?
The research on cytotoxic T lymphocytes, specifically targeting the BK virus, suggests that these cells can be generated and used safely in humans, as they show specificity for the virus and minimal reactivity against non-infected cells. This indicates a potential for safe application in treating virus-related conditions, although specific safety data for cancer treatment is not detailed in the studies.12346
How is the treatment Allogeneic BK-specific Cytotoxic T-lymphocytes unique for virus-related cancer?
This treatment is unique because it uses donor-derived cytotoxic T-lymphocytes (a type of immune cell) specifically targeted against BK virus, which is associated with certain cancers. Unlike traditional treatments, it harnesses the body's immune system to specifically attack virus-infected cancer cells, potentially offering a more targeted approach.7891011
Research Team
Amanda Olson
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for patients with various malignancies, HIV/AIDS, history of organ transplant, or Merkel cell carcinoma linked to BK/JC viruses. Participants must have measurable disease and be willing to use contraception if applicable. Excluded are those on high-dose steroids, recent recipients of certain immune therapies, or with active severe infections.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive allogeneic BK-specific cytotoxic T-lymphocytes intravenously over 30 minutes. Eligible patients may receive up to 19 additional infusions at least 2 weeks apart.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of acute GVHD and adverse events.
Treatment Details
Interventions
- Allogeneic BK-specific Cytotoxic T-lymphocytes (CAR T-cell Therapy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator