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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
Must not have
Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment
Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, and willing to use birth control during the study.
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I am taking steroids equivalent to more than 0.5 mg/kg of prednisone at the time of my treatment.
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I have severe acute or extensive chronic GVHD.
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I have not received Thymoglobulin or Alemtuzumab in the last 30 days.
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I am mostly bedridden and unable to care for myself.
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I have been diagnosed with HIV.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,794 Total Patients Enrolled
Medical College of WisconsinOTHER
635 Previous Clinical Trials
1,181,662 Total Patients Enrolled
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,227,770 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,339 Previous Clinical Trials
14,881,746 Total Patients Enrolled
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,887,910 Total Patients Enrolled
New York Medical CollegeLead Sponsor
71 Previous Clinical Trials
6,114 Total Patients Enrolled
Mitchell S Cairo, MDPrincipal InvestigatorNew York Medical College
14 Previous Clinical Trials
1,128 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
~0 spots leftby Dec 2024
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