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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
Patients with any type of malignancies; and/or HIV/AIDs; and/or history of solid organ transplant; and/or Merkel polyoma-virus related Merkel cell tumor(s) with measurable disease on imaging per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone
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 have cancer, HIV/AIDS, a history of organ transplant, or Merkel cell tumors with measurable disease.
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I can reduce my steroid use to less than 0.5 mg/kg/day of prednisone.
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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 completed my last anti-BK CTL infusion and its follow-up assessments 6 weeks ago.
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I am on antiviral treatments like cidofovir or leflunomide but they are not working.

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
2,966 Previous Clinical Trials
1,804,681 Total Patients Enrolled
1 Trials studying BK Virus Infection
30 Patients Enrolled for BK Virus Infection
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,025 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
~3 spots leftby Jul 2024