EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection

Part of paid clinical trials in Los Angeles, California.

Sponsor
New York Medical College
Study ID
NCT03266653
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Epstein-Barr Virus Infections
  • Primary Immune Deficiency Disorder

Eligibility Criteria

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

Interventions

  • cytotoxic t-lymphocytes — DRUG
    EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs.

Study Details

Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV 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
Jul 7, 2020
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 EBV
    Patients with refractory EBV will get one dose of EBV specific CTLs. If they don't show a response based on EBV PCRs, patients may get up to another 4 doses of EBV-CTLs (5 doses maximum)

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 (8)

FacilityCityStateZIPSite coordinators
Children's Hosptial Los AngelesLos AngelesCalifornia90027
Neena Kapoor, MD
[email protected]
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 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 Hosptial Los Angeles· Los Angeles, CAUniversity of California San Francisco· San Francisco, CAJohns Hopkins· Baltimore, MDWashington University· St Louis, MONew York Medical College· Valhalla, NYNationwide Children's Hosptial· Columbus, OH

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