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CAR T-cell Therapy

BK CTL for Viral Infections

Phase 1 & 2

Recruiting

Led By Mitchell S Cairo, MD

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs)

Age: 0.1 to 30.99 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will test whether a new treatment for BK virus infection is safe and effective. The treatment involves using a person's own immune cells to target the virus. This trial will enroll children, adolescents, and young adults who have not responded to other treatments or who have primary immunodeficiencies.

Who is the study for?

This trial is for children, adolescents, and young adults aged 0.1 to 30.99 years with stubborn BK virus infections after a stem cell or organ transplant or those with primary immunodeficiencies. Participants must have tried antiviral treatments without success or cannot tolerate them due to side effects like kidney damage.Check my eligibility

What is being tested?

The study tests whether special immune cells called BK cytotoxic T cells (CTLs) can reduce the BK virus in patients who haven't responded well to other treatments post-transplantation or those with immune deficiencies.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions related to immune cell infusions such as fever, chills, fatigue, headache, muscle pain, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most of my daily activities without help.

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I am younger than 31 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Design

1Treatment groups

Experimental Treatment

Group I: BK CTLExperimental Treatment1 Intervention

Eligible patients with refractory BK infection will receive up to 5 infusions of BK CTLs that are donor derived.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,581,019 Total Patients Enrolled

Medical College of WisconsinOTHER

609 Previous Clinical Trials

1,162,543 Total Patients Enrolled

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,466 Total Patients Enrolled

Media Library

BK CTL (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04197596 — Phase 1 & 2

Primary Immunodeficiency Research Study Groups: BK CTL

Primary Immunodeficiency Clinical Trial 2023: BK CTL Highlights & Side Effects. Trial Name: NCT04197596 — Phase 1 & 2

BK CTL (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04197596 — Phase 1 & 2

Frequently Asked Questions

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

Are there multiple healthcare facilities conducting this investigation within the US?

"This research project is recruiting from 8 different medical sites, including Washington University in Saint Louis, Johns Hopkins in Baltimore, and Children's Hospital of Pennsylvania in Philadelphia. Additionally, there are other recruitment centres located around the United States."

Answered by AI

Is this investigation actively searching for participants?

"Indeed, according to the details procured from clinicaltrials.gov this medical trial is still recruiting participants. It was initially posted on July 1st 2020 and has since been modified on October 24th 2022. 40 patients are required for enrolment at 8 distinct healthcare facilities."

Answered by AI

Who is eligible to participate in this medical experiment?

"This medical trial is open to 40 applicants with antibody deficiency syndrome between infancy and 30 years of age. Participants must meet a range of criteria, such as being prescribed steroids (0.5mg/kg prednisone equivalent) for their condition, having received donor lymphocyte infusion within the past month, exhibiting renal toxicity due to cidofovir or another grade 2 toxic side effect from this drug, giving written informed consent prior to study-related procedures, demonstrating an appropriate performance status based on Karnofsky/Lansky scores, providing evidence of not being pregnant through urine tests if applicable; experiencing acute GVHD at least Grade 2"

Answered by AI

Does this research program take into consideration participants who are more than 45 years of age?

"This medical trial requires that participants be between the age of one month and thirty years."

Answered by AI

How many participants are contributing to the results of this research?

"Affirmative. As documented on clinicaltrials.gov, recruitment for this study is still ongoing since it was first published on July 1st 2020 and last modified October 24th 2022. 40 participants are currently being sought at 8 different trial sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

2020. "Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04197596.

All > Primary Immunodeficiency