Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

Part of paid clinical trials in Los Angeles, California.

Sponsor
New York Medical College
Study ID
NCT03266640
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cytomegalovirus Infections
  • Primary Immune Deficiency Disorder

Eligibility Criteria

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

Interventions

  • viral specific cytotoxic t-lymphocytes — DRUG
    CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.

Study Details

CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) 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: Refractory CMV
    Patients with refractory CMV will be given one dose of CMV specific CTLs. HLA matched donors will get Dose 2.5 × 10(4) CD3/kg recipient weight; HLA mismatched will get 0.5x10(4) CD3/kg recipient weight. Additional doses may be given for a total of 5 doses if patients do not have a response to the first dose with a reduction in viral load to normal limits.

Primary Outcome Measure

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

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Neena Kapoor, MD
[email protected]
University of California San FranciscoSan FranciscoCalifornia94158
Julia Chu, MD
[email protected]
Indiana UniversityIndianapolisIndiana46202
Emily Hopewell, MD
[email protected]
Johns HopkinsBaltimoreMaryland21287
Kenneth Cooke, MD
Washington UniversitySt LouisMissouri63130
Shalini Shenoy, MD
[email protected]
New York Medical CollegeValhallaNew York10595
Mitchell S Cairo, MD
[email protected]
914-594-2150
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 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, CAIndiana University· Indianapolis, INJohns Hopkins· Baltimore, MDWashington University· St Louis, MONew York Medical College· Valhalla, NY

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