~2 spots leftby Jul 2025

Cytotoxic T Lymphocytes for Virus-Related Cancer

AL
Overseen ByAmanda L. Olson, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must be taking: Antivirals
Must not be taking: Prednisone, ATG, DLI, Campath
Disqualifiers: Uncontrolled infections, Active acute GVHD, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions

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?

Research shows that BK-specific T cells can be expanded and used to target BK virus infections, particularly in kidney transplant patients, suggesting that similar T cell therapies could be effective in treating virus-related cancers by enhancing the body's immune response to the virus.12345

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 L. Olson | MD Anderson Cancer Center

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

I have cancer, HIV/AIDS, a history of organ transplant, or Merkel cell tumors with measurable disease.
I can reduce my steroid use to less than 0.5 mg/kg/day of prednisone.
I am not pregnant and willing to use birth control during the study.
See 4 more

Exclusion Criteria

I am currently experiencing moderate to severe symptoms of graft-versus-host disease.
I am not currently on high doses of prednisone, nor have I recently received ATG, DLI, or Campath treatments.
I don't have any uncontrolled infections or I've been stable on treatment for them.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 56 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of acute GVHD and adverse events.

12 months

Treatment Details

Interventions

  • Allogeneic BK-specific Cytotoxic T-lymphocytes (CAR T-cell Therapy)
Trial OverviewThe study tests donor-derived cytotoxic T lymphocytes (CTLs) against BK and JC viruses in patients with related malignancies. CTLs are blood cells grown in a lab designed to fight these specific viral infections that can complicate transplants.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (BK-specific cytotoxic T lymphocytes)Experimental Treatment2 Interventions
Patients receive allogeneic BK-specific cytotoxic T-lymphocytes IV over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 19 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

The study identifies a method to effectively capture and expand BKV-specific CD4(+) T cells from kidney transplant patients, which is crucial for improving immune responses against BK virus reactivation.
BKV-specific CD4(+) T cells were found to be multifunctional and cytolytic, indicating their significant role in controlling BKV replication, thus highlighting their potential for use in adoptive immunotherapy.
The role of CD4(+) T cells in BKV-specific T cell immunity.Weist, BJ., Schmueck, M., Fuehrer, H., et al.[2021]
A new method to monitor BKV-specific T-cell immunity was developed, allowing for the detection of CD4+ and CD8+ T-cell responses in kidney transplant patients with high levels of BKV-DNA, which is crucial for understanding the immune response to polyoma BK virus.
This method can help assess how reducing immunosuppression affects BKV immunity and the role of specific T cells in the development of polyoma BK virus-associated nephropathy (PVAN), highlighting its potential for improving patient management in transplant settings.
HLA type-independent method to monitor polyoma BK virus-specific CD4 and CD8 T-cell immunity.Hammer, MH., Brestrich, G., Andree, H., et al.[2023]
BKV-specific CD8(+) T cells are present in low frequencies in healthy individuals and have a unique memory phenotype, which suggests they may play a role in controlling BK virus reactivation in immunocompromised patients.
These T cells exhibit limited direct cytotoxic capacity but are polyfunctional, capable of producing key cytokines like IL-2 and IFN-γ, indicating their potential importance in antiviral immune responses.
Phenotypic and functional characterization of circulating polyomavirus BK VP1-specific CD8+ T cells in healthy adults.van Aalderen, MC., Remmerswaal, EB., Heutinck, KM., et al.[2021]

References

The role of CD4(+) T cells in BKV-specific T cell immunity. [2021]
HLA type-independent method to monitor polyoma BK virus-specific CD4 and CD8 T-cell immunity. [2023]
Phenotypic and functional characterization of circulating polyomavirus BK VP1-specific CD8+ T cells in healthy adults. [2021]
Dendritic cells pulsed with polyomavirus BK antigen induce ex vivo polyoma BK virus-specific cytotoxic T-cell lines in seropositive healthy individuals and renal transplant recipients. [2022]
Functional characterization of BK virus-specific CD4+ T cells with cytotoxic potential in seropositive adults. [2008]
Cell-mediated immune reaction against BK virus-transformed cells. [2019]
Establishment of human cytotoxic T cell lines specific for human adult T cell leukemia virus-bearing cells. [2006]
Are cytotoxic T cells a common homeostatic mechanism in responses to viruses, homografts and tumours? [2005]
Long-term human cytolytic T-cell lines allospecific for HLA-DR6 antigen are OKT4+. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Immunotherapy with a tumor-infiltrating lymphocyte clone, soluble antigen, and cyclophosphamide. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Pharmacotherapy versus T lymphocytes for CMV. [2021]