← Back to Search

CAR T-cell Therapy

Cytotoxic T Lymphocytes for Virus-Related Cancer

Phase 2
Recruiting
Led By Amanda Olson
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study
Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood polymerase chain reaction (PCR) positive for BK virus and/or JC viral encephalitis
Must not have
Patients with active acute graft-versus-host disease (GVHD) grades II-IV
Patients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Summary

This trial is testing how well cytotoxic T lymphocytes from donors can treat patients with cancer caused by BK or JC viruses.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While the description doesn't specify side effects, similar treatments may cause immune reactions, fatigue, fever, chills or risk of infection due to the introduction of foreign immune cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant and willing to use birth control during the study.
Select...
I have blood in my urine or kidney inflammation due to BK virus, confirmed by a PCR test.
Select...
I am on antiviral treatments like cidofovir or leflunomide but they are not working.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently experiencing moderate to severe symptoms of graft-versus-host disease.
Select...
I am not currently on high doses of prednisone, nor have I recently received ATG, DLI, or Campath treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graft-vs-Host Disease
Incidence of adverse events
Response, defined as response (R) = (best response [R1] or second best response [R2])
Secondary outcome measures
Glomerular filtration rate
Overall survival

Trial Design

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 Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,179 Total Patients Enrolled
1 Trials studying BK Virus Infection
30 Patients Enrolled for BK Virus Infection
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,301 Total Patients Enrolled
1 Trials studying BK Virus Infection
30 Patients Enrolled for BK Virus Infection
Amanda OlsonPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
155 Total Patients Enrolled

Media Library

Allogeneic BK-specific Cytotoxic T-lymphocytes (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02479698 — Phase 2
BK Virus Infection Research Study Groups: Treatment (BK-specific cytotoxic T lymphocytes)
BK Virus Infection Clinical Trial 2023: Allogeneic BK-specific Cytotoxic T-lymphocytes Highlights & Side Effects. Trial Name: NCT02479698 — Phase 2
Allogeneic BK-specific Cytotoxic T-lymphocytes (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02479698 — Phase 2
~0 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top