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

Phase 2

Recruiting

• Conditions: Primary Immune Deficiency Disorder; Cytomegalovirus Infections
• Interventions: Drug: viral specific cytotoxic t-lymphocytes

• Registration Number: NCT03266640
• Lead Sponsor: New York Medical College

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Study Start: 2018-11-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Refractory CMV	viral specific cytotoxic t-lymphocytes	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 Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Patients will be followed for 12 weeks after each infusion	Patients will be monitored for adverse events following the administration of CMV CTLs
Incidence of Response to Treatment	Patients will be followed 12 weeks after each infusion	Patients will be followed for improvement in viral infection by monitoring CMV PCR weekly for response to treatment with CTLs

Trial Locations

Locations (9)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

New York Medical College; 🇺🇸 Valhalla, New York, United States

Children's Hospital of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Nationwide Children's Hosptial; 🇺🇸 Columbus, Ohio, United States

Medical College of Wisconsin/Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States