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

Phase 1

Recruiting

• Conditions: Primary Immune Deficiency Disorder; Viral Infection
• Interventions: Biological: BK CTL

• Registration Number: NCT04197596
• Lead Sponsor: New York Medical College

Brief Summary

BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Study Start: 2020-07-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

.1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either

• Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR

• Medical intolerance to anti-viral therapies including:

  • 2 renal toxicity with cidofovir or other > grade 2 toxicities secondary to cidofovir And/or

• known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.

1.3 Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test

Exclusion:

1. Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTL infusion
2. Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
4. Thymoglobulin (ATG) or Alemtuzumab within 30 days
5. Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30%
6. Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection.
7. Any medical condition which could compromise participation in the study according to the investigator's assessment
8. Known HIV infection
9. 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.
10. Known hypersensitivity to iron dextran
11. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
12. Known human anti-mouse antibodies

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	12 weeks	Patients will be monitored for adverse events following each CTL infusion

Trial Locations

Locations (8)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Nationwide Children's Hosptial; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Colorado; 🇺🇸 Aurora, Colorado, United States

Children's Hospital of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

New York Medical College; 🇺🇸 Valhalla, New York, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States