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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study 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

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I am not pregnant and willing to use birth control during the study.

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I have blood in my urine or kidney inflammation due to BK virus, confirmed by a PCR test.

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I am on antiviral treatments like cidofovir or leflunomide but they are not working.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,221 Total Patients Enrolled

1 Trials studying BK Virus Infection

30 Patients Enrolled for BK Virus Infection

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,781 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any fresh participants being accepted into the experimental protocol?

"Clinicaltrials.gov indicates that this clinical trial is actively recruiting, having been first posted on July 23rd 2015 and revised as recently as October 10th 2022."

Answered by AI

Has the United States Food and Drug Administration authorized Allogeneic BK-specific Cytotoxic T-lymphocytes?

"The team at Power rated the safety of Allogeneic BK-specific Cytotoxic T-lymphocytes with a 2, as it is currently in Phase 2 trials and has only been tested for its safety."

Answered by AI

How many individuals have registered to take part in this clinical experiment?

"Affirmative. According to details provided on clinicaltrials.gov, this medical trial initiated recruitment efforts in July of 2015 and is still ongoing as evidenced by its last edit date of October 10th 2022. The study requires 100 volunteers at a single location for participation eligibility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

2015. "Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02479698.

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