Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

Part of paid clinical trials in Los Angeles, California.

Sponsor
New York Medical College
Study ID
NCT03266627
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Adenovirus
  • Primary Immune Deficiency Disorder

Eligibility Criteria

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

Interventions

  • cytotoxic t-lymphocytes — DRUG
    adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.

Study Details

Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD

Key Dates

Start date
Nov 1, 2018
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: patients with adenoviral infection
    patients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions.

Primary Outcome Measure

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

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Neena Kapoor, MD
[email protected]
University of California San FranciscoSan FranciscoCalifornia94158
Julia Chu, MD
[email protected]
Children's Hospital of ColoradoAuroraColorado80045
Michael Verneris, MD
[email protected]
720-777-1234
Amanda Kinderman, MPH
[email protected]
303-724-3652
University of Colorado DenverAuroraColorado80045
Michael Verneris, MD
[email protected]
Indiana UniversityIndianapolisIndiana46202
Emily Hopewell, MD
[email protected]
Johns HopkinsBaltimoreMaryland21287
Kenneth Cooke, MD
Washington UniversitySt LouisMissouri63130
Shalini Shenoy, MD
[email protected]
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 Wisconsin/Children's Hospital of WisconsinMilwaukeeWisconsin53226
Julie A Talano, MD
[email protected]
414-955-4185
Meredith Beversdorf, RN
[email protected]
(414) 266-5891

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CAUniversity of California San Francisco· San Francisco, CAChildren's Hospital of Colorado· Aurora, COUniversity of Colorado Denver· Aurora, COIndiana University· Indianapolis, INJohns Hopkins· Baltimore, MD

Related Studies