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CAR T-cell Therapy

CTL Therapy for BK Virus Infection (BK-CTLs Trial)

Phase < 1
Recruiting
Led By Nancy J Bunin, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 0.1 to 25 years
Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks after last bk-ctl infusion
Awards & highlights

BK-CTLs Trial Summary

This trial will test whether a manufactured immune cell can decrease a specific virus in patients who have received a stem cell transplant, kidney transplant, or chemotherapy.

Who is the study for?
This trial is for immunocompromised transplant patients aged 0.1 to 25 years with BK virus infections post-transplant or chemotherapy, experiencing symptoms like blood in urine and pain during urination. Participants need a related donor with T-cell response to the virus, must not be on certain steroids or other experimental treatments for BK virus, and should have a performance status over 30%. Pregnant women and those unwilling to use birth control are excluded.Check my eligibility
What is being tested?
The study tests whether special immune cells called BK-virus specific CTLs can reduce viral load in patients with BK Virus after stem cell or kidney transplants, or chemotherapy. These CTLs are made using a system called Miltenyi CliniMACS Prodigy Gamma-capture.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with transfusions such as allergic reactions, fever, chills, shortness of breath; there's also a risk of GVHD (graft-versus-host disease) where donated cells attack the patient's body.

BK-CTLs Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 month and 25 years old.
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I can do most of my daily activities by myself.
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I have a donor whose immune cells react to a specific virus.
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My original donor is available and has tested positive for BK virus.
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I have symptoms of a bladder infection and high BK virus levels after a stem cell transplant or chemotherapy.

BK-CTLs Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks after last bk-ctl infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks after last bk-ctl infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Grade III-IV acute GVHD
Number of patients with undetectable BK viral load

BK-CTLs Trial Design

1Treatment groups
Experimental Treatment
Group I: BK cystitis and/or nephropathyExperimental Treatment1 Intervention
All patients with symptoms that are consistent with BK cystitis and/or nephropathy (frequency, dysuria, hematuria, elevated creatinine) will have serum quantitative DNA PCR for BK virus level measured in log copies per mL (results also expressed in copies per milliliter), performed in the Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory

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Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,582,800 Total Patients Enrolled
Nancy J Bunin, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
3 Previous Clinical Trials
333 Total Patients Enrolled

Media Library

BK-virus specific CTLs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04293042 — Phase < 1
BK Virus Research Study Groups: BK cystitis and/or nephropathy
BK Virus Clinical Trial 2023: BK-virus specific CTLs Highlights & Side Effects. Trial Name: NCT04293042 — Phase < 1
BK-virus specific CTLs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04293042 — Phase < 1

Frequently Asked Questions

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

How many participants are being canvassed for this experiment?

"Yes, the clinical trial can be found on clinicaltrials.gov and is actively seeking participants. Originally posted on October 7th 2019, it was recently modified on March 15th 2022 with an objective to enrol 20 patients at a single site."

Answered by AI

Is enrollment for this clinical trial still open?

"As per clinicaltrials.gov, this trial is seeking participants with the most recent update occurring on March 15th 2022 - it was initially posted to the website October 7th 2019."

Answered by AI

Who qualifies to participate in this investigation?

"To qualify for this research study, subjects must possess bk virus and be between 5 Weeks to 25 years of age. At present, the team seeks to recruit 20 participants."

Answered by AI

Is the enrollment period open to octogenarian patients?

"As outlined in the selection guidelines, individuals who are aged between 5 Weeks and 25 years may join this medical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
Nancy Bunin 2019. "Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04293042.
~3 spots leftby Jan 2025
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