Trials Sponsors Conditions Drugs Pricing

Conditions

Acquired Immunodeficiency Adenovirus Adenovirus Infection BK Viremia BK Virus Infection CMV Viremia Cytomegalovirus Enteritis EBV Viremia Epstein Barr Virus Infection Epstein-Barr Virus Infection Reactivation Inherited Immunodeficiency Diseases Opportunistic Viral Infection Post-transplant Lymphoproliferative Disorder Primary Immunodeficiency Refractory Viral Infection Severe Combined Immunodeficiency (SCID)Solid Organ Transplant Complications Stem Cell Transplant Complications Viremia

Keywords

Cytotoxic T LymphocytesvCTLVirus-Specific T CellsvCTL TherapyCellular ImmunotherapyAdoptive T-Cell TherapyAntiviral ImmunotherapyPediatric TransplantViral ReactivationResistant Viral InfectionCliniMACS Cytokine Capture System

Outcome Measures

Primary Outcomes (2)

Occurrence of Grade 3 or higher acute graft-versus-host disease (GVHD)
This outcome measures the number of participants who develop Grade 3 or higher acute graft-versus-host disease that is assessed as possibly, probably, or definitely related to vCTL infusion. Acute GVHD will be graded using the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria.
From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion
Occurrence of Grade 3 or higher infusion-related reactions
This outcome measures the number of participants who experience a Grade 3 or higher infusion-related reaction that is assessed as possibly, probably, or definitely related to vCTL infusion. Infusion-related reactions will be graded using NCI CTCAE version 6.0.
From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

Study Arms (1)

Virus-Specific Cytotoxic T Lymphocytes (vCTLs)

EXPERIMENTAL

Participants with refractory CMV, ADV, EBV, and/or BK virus will receive donor-derived virus-specific cytotoxic T lymphocytes. Participants may receive a multivirus-specific product when clinically indicated. The initial infusion is administered on Day 0. Repeat infusions may be administered every 2 weeks, up to five total infusions, for ongoing detectable viral replication if eligibility criteria are met.

Biological: Virus-Specific Cytotoxic T Lymphocytes (vCTLs)

Interventions

Virus-Specific Cytotoxic T Lymphocytes (vCTLs)Biological

Donor-derived virus-specific cytotoxic T lymphocytes (vCTLs) targeting one or more of cytomegalovirus (CMV), adenovirus (ADV), Epstein-Barr virus (EBV), and BK virus. Cells are manufactured using the CliniMACS® Prodigy and CliniMACS Cytokine Capture System (IFN-γ) following stimulation with virus-specific PepTivator® peptide pools. vCTLs are administered by IV infusion at a dose of 2-3 × 10\^4 CD3+ cells/kg recipient weight for HLA-matched related donors or 0.4-0.6 × 10\^4 CD3+ cells/kg recipient weight for HLA-mismatched related donors. Additional infusions of the same dose may be administered every 2 weeks in subjects with ongoing clinically significant viral infection who continue to meet infusion eligibility criteria, for up to 5 total infusions. The intervention is intended for treatment of refractory viral infections in patients with inherited or acquired immunodeficiencies, including recipients of hematopoietic stem cell transplant.

Also known as: vCTLs, Virus-specific T cells, Cytotoxic T lymphocyte therapy, Gamma-Capture Virus-Specific Cytotoxic T Lymphocytes, CliniMACS-Manufactured Virus-Specific Cytotoxic T Lymphocytes, Virus-Specific T Cells (VSTs), Donor-Derived Virus-Specific Cytotoxic T Lymphocytes

Virus-Specific Cytotoxic T Lymphocytes (vCTLs)

Eligibility Criteria

Age0 Years - 29 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Subjects with inherited (e.g. SCID) or acquired immunodeficiency with evidence of refractory viral infection with one or more of CMV, adenovirus, EBV, or BK virus. Specifically:
Increasing viremia by quantitative PCR with increase from baseline over 7 days, or persistent detection after 14 days despite appropriate standard of care therapy (e.g. anti-viral therapy, withdrawal of immunosuppression), AND/OR

Sponsors & Collaborators

Children's Hospital of Philadelphia
Otherlead

Related Publications (66)

Mahadeo KM, Baiocchi R, Beitinjaneh A, Chaganti S, Choquet S, Dierickx D, Dinavahi R, Duan X, Gamelin L, Ghobadi A, Guzman-Becerra N, Joshi M, Mehta A, Navarro WH, Nikiforow S, O'Reilly RJ, Reshef R, Ruiz F, Spindler T, Prockop S. Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial. Lancet Oncol. 2024 Mar;25(3):376-387. doi: 10.1016/S1470-2045(23)00649-6. Epub 2024 Jan 31.
PMID: 38309282BACKGROUND
Nikiforow S, Whangbo JS, Reshef R, Tsai DE, Bunin N, Abu-Arja R, Mahadeo KM, Weng WK, Van Besien K, Loeb D, Nasta SD, Nemecek ER, Zhao W, Sun Y, Galderisi F, Wahlstrom J, Mehta A, Gamelin L, Dinavahi R, Prockop S. Tabelecleucel for EBV+ PTLD after allogeneic HCT or SOT in a multicenter expanded access protocol. Blood Adv. 2024 Jun 25;8(12):3001-3012. doi: 10.1182/bloodadvances.2023011626.
PMID: 38625984

MeSH Terms

Conditions

Adenoviridae InfectionsViremiaEpstein-Barr Virus InfectionsVirus DiseasesPrimary Immunodeficiency DiseasesSevere Combined Immunodeficiency

Condition Hierarchy (Ancestors)

DNA Virus InfectionsInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHerpesviridae InfectionsTumor Virus Infections

Study Officials

Caitlin Elgarten, MD, MSCE
Children's Hospital of Philadelphia
PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Atkinson

CONTACT

215-590-2820 cttsbmtintake@chop.edu

Kellie Patterson, BSN, RN

CONTACT

215-590-2820

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 14, 2026

Study Start

November 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

November 2036

Estimated

25BT056: Basket Study of Viral Cytotoxic T Lymphocytes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Virus-Specific Cytotoxic T Lymphocytes (vCTLs)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (66)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (12)

You may not qualify if:

Data Sharing

Source record

25BT056: Basket Study of Viral Cytotoxic T Lymphocytes

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Virus-Specific Cytotoxic T Lymphocytes (vCTLs)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (66)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (12)

You may not qualify if:

Data Sharing

Source record