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

Primary Purpose

Viral Infection, Primary Immune Deficiency Disorder

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BK CTL
Sponsored by
New York Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Infection

Eligibility Criteria

1 Month - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 30.99 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

Sites / Locations

  • University of California San FranciscoRecruiting
  • Children's Hospital of ColoradoRecruiting
  • Johns HopkinsRecruiting
  • Washington UniversityRecruiting
  • New York Medical CollegeRecruiting
  • Nationwide Children's HosptialRecruiting
  • Children's Hospital of PennsylvaniaRecruiting
  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BK CTL

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 11, 2019
Last Updated
October 24, 2022
Sponsor
New York Medical College
Collaborators
Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital, Johns Hopkins University, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04197596
Brief Title
Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
Official Title
A Pilot Study in the Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York Medical College
Collaborators
Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital, Johns Hopkins University, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Infection, Primary Immune Deficiency Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BK CTL
Arm Type
Experimental
Arm Description
Eligible patients with refractory BK infection will receive up to 5 infusions of BK CTLs that are donor derived.
Intervention Type
Biological
Intervention Name(s)
BK CTL
Intervention Description
Patient with refractory BK infection and a HLA Matched Related Donors: BK specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg). Patients with refractory BK virus and a HLA Mismatched Related Donors: BK specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg).
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Patients will be monitored for adverse events following each CTL infusion
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 30.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test Exclusion: Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTL infusion Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion Thymoglobulin (ATG) or Alemtuzumab within 30 days Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection. Any medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection 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. Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent. Known human anti-mouse antibodies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell S Cairo, MD
Phone
9145942150
Email
mitchell_cairo@nymc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Harrison
Phone
16172857844
Email
lauren_harrison@nymc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S Cairo, MD
Organizational Affiliation
New York Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Chu, MD
Email
Julia.Chu2@ucsf.edu
Facility Name
Children's Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Verneris, MD
Phone
720-777-1234
Email
Michael.Verneris@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Amanda Kinderman, MPH
Phone
303-724-3652
Email
amanda.kinderman@ucdenver.edu
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Cooke, MD
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalini Shenoy, MD
Email
shalinishenoy@wustl.edu
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell S Cairo, MD
Phone
914-594-2150
Email
mitchell_cairo@nymc.edu
First Name & Middle Initial & Last Name & Degree
Lauren Harrison, RN
Phone
6172857844
Email
lauren_harrison@nymc.edu
First Name & Middle Initial & Last Name & Degree
Mitchell S. Cairo, MD
Facility Name
Nationwide Children's Hosptial
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean Lee, MD, PhD
Phone
614-722-3550
Email
Dean.Lee@nationwidechildrens.org
Facility Name
Children's Hospital of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Bunin, MD
Phone
215-590-2255
Email
buninn@email.chop.edu
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie A Talano, MD
Phone
414-955-4185
Email
jtalano@mcw.edu
First Name & Middle Initial & Last Name & Degree
Julie A Talano, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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