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

Part of paid clinical trials in San Francisco, California.

Sponsor
New York Medical College
Study ID
NCT04197596
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Primary Immune Deficiency Disorder
  • Viral Infection

Eligibility Criteria

Sex
ALL
Age
1 Month - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • BK CTL — BIOLOGICAL
    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 twenty 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).

Study Details

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).

Key Dates

Start date
Jul 1, 2020
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BK CTL
    Eligible patients with refractory BK infection will receive up to 20 infusions of BK CTLs that are donor derived.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 12 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158
Julia Chu, MD
[email protected]
Johns HopkinsBaltimoreMaryland21287
Kenneth Cooke, MD
Washington UniversitySt LouisMissouri63130
Shalini Shenoy, MD
[email protected]
New York Medical CollegeVallhalaNew York10595
Mitchell S Cairo, MD
[email protected]
914-594-2150
Lauren Harrison, RN
[email protected]
6172857844
Mitchell S. Cairo, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HosptialColumbusOhio43205
Dean Lee, MD, PhD
[email protected]
(614) 722-3550
Children's Hospital of PennsylvaniaPhiladelphiaPennsylvania19104
Nancy Bunin, MD
[email protected]
215 590-2255
Medical College of WisconsinMilwaukeeWisconsin53226
Julie A Talano, MD
[email protected]
414-955-4185
Meredith Beversdorf, RN
[email protected]
(414) 266-5891
Julie A Talano, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CAJohns Hopkins· Baltimore, MDWashington University· St Louis, MONew York Medical College· Vallhala, NYNationwide Children's Hosptial· Columbus, OHChildren's Hospital of Pennsylvania· Philadelphia, PA

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