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Not yet recruitingNCT07873970Updated Oct 22, 2026

25BT056: Basket Study of Viral Cytotoxic T Lymphocytes

An Early Phase 1 interventional study of Virus-Specific Cytotoxic T Lymphocytes (vCTLs) in EBV Viremia, CMV Viremia and BK Viremia, sponsored by Children's Hospital of Philadelphia. Not yet recruiting. Open to participants aged 0 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Children's Hospital of Philadelphia · Early Phase 1, Interventional, and Treatment

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
0 Years to 29 Years
Sex
All
01

Study summary

This study is evaluating the safety and effectiveness of virus-specific cytotoxic T lymphocytes (vCTLs) for treating difficult-to-control viral infections caused by cytomegalovirus (CMV), adenovirus (ADV), Epstein-Barr virus (EBV), or BK virus in children, adolescents, and young adults with weakened immune systems. Eligible participants include recipients of hematopoietic stem cell transplantation, solid organ transplantation, and patients with primary immunodeficiency disorders.

vCTLs are immune cells collected from a related donor and selected to recognize and fight specific viruses. The cells are manufactured using the CliniMACS® Cytokine Capture System and administered by intravenous infusion. Additional infusions may be given if viral infection persists.

The study will assess the safety of vCTL therapy, including the risk of graft-versus-host disease (GVHD) and infusion-related reactions, as well as its ability to reduce viral infection, improve clinical outcomes, and support survival. Participants will be monitored for approximately 12 weeks after their final vCTL infusion. Participants will all receive vCTLs; there is no comparison group.

Participants will:

  1. Have donor-derived vCTLs manufactured for infusion using the CliniMACS Cytokine Capture System
  2. Receive the vCTLs through an intravenous infusion
  3. Be monitored for side effects and infusion reactions, viral levels through blood testing, clinical outcomes, including response to treatment, survival, and time without detectable virus
Read the detailed description

Viral infection and reactivation are major causes of morbidity and mortality in individuals with inherited or acquired immunodeficiency, including recipients of allogeneic hematopoietic stem cell transplant and solid organ transplant. Cytomegalovirus, adenovirus, Epstein-Barr virus, and BK virus may cause severe, persistent, or progressive disease. Standard antiviral therapies may be ineffective, poorly tolerated, contraindicated, or limited by viral resistance.

This is a single-institution, open-label, prospective pilot basket study of donor-derived virus-specific cytotoxic T lymphocytes for treatment of refractory CMV, adenovirus, EBV, and/or BK virus infection. The vCTL product is manufactured from an adult related donor with at least a 3/6 human leukocyte antigen (HLA) match to the recipient. Following leukapheresis, donor cells are stimulated with virus-specific peptide pools and enriched for interferon-gamma-secreting T cells using the CliniMACS Cytokine Capture System on the CliniMACS Prodigy platform.

Participants will receive vCTLs by slow intravenous push. Dose is based on donor-recipient HLA matching. Additional infusions of the same dose may be administered every 2 weeks for persistent detectable viral replication, up to a maximum of five infusions, provided safety and redosing criteria are met.

Safety will be evaluated in aggregate across all viral cohorts, with particular focus on Grade 3 or higher acute graft-versus-host disease and Grade 3 or higher infusion-related reactions considered at least possibly related to vCTL infusion. Antiviral efficacy will be evaluated separately by virus type using quantitative polymerase chain reaction and clinical response assessments. Participants will be followed through 12 weeks after their final vCTL infusion.

02

Conditions studied

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

Keywords

  • Cytotoxic T Lymphocytes
  • vCTL
  • Virus-Specific T Cells
  • vCTL Therapy
  • Cellular Immunotherapy
  • Adoptive T-Cell Therapy
  • Antiviral Immunotherapy
  • Pediatric Transplant
  • Viral Reactivation
  • Resistant Viral Infection
  • CliniMACS Cytokine Capture System
03

In context

Adenoviridae Infections

108 studies on the registry are indexed under Adenoviridae Infections; 33 are open to participants now.

This study's planned enrollment of 35 is close to the median of 35 across 84 interventional studies indexed under Adenoviridae Infections.

Browse Adenoviridae Infections studies →

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 488 studies on the registry; 91 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Browse Children's Hospital of Philadelphia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Recipient Inclusion Criteria

  1. 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:

    1. 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
    2. Progressive symptomatic viral infection evidenced by persistent clinical symptoms or end-organ disease attributable to the viral infection that has not improved after at least 7 days of appropriate standard-of-care therapy, or develops new clinical manifestations despite standard-of-care therapy, AND/OR
    3. Antiviral resistance, or inability to receive appropriate antiviral therapy due to intolerance, toxicity, contraindication, or lack of a feasible antiviral treatment option.
  2. Age 0 - 29 years at time of consent
  3. Female subjects of reproductive potential, defined per Oncology clinical guidelines as all females ≥ 12 years old, or \<12 years old who have reached menarche, must have a negative urine or serum pregnancy test. Testing may be performed using serum human chorionic gonadotropin (HCG) or urine
  4. Subjects with reproductive potential must agree to use an effective method of birth control

Recipient Exclusion Criteria

  1. Subjects with ≥ Grade 2 acute GVHD or moderate to severe chronic GVHD at the time of vCTL infusion
  2. Subjects receiving systemic steroids (> 0.5mg/kg/day prednisolone equivalent) at the time of vCTL infusion
  3. Receipt of donor lymphocyte infusion within the 4 weeks preceding vCTL infusion
  4. Receipt of thymoglobulin, alemtuzumab, or other T cell immunosuppressive monoclonal antibody within the 4 weeks preceding vCTL infusion
  5. End-organ involvement of virus in sites that may, in the opinion of the investigator, put the subject at risk of unacceptable toxicity e.g. retinitis, cerebritis, encephalitis
  6. Known HIV infection
  7. Any medical condition which could compromise participation in the study, in the opinion of the investigator
  8. Female subjects who are pregnant or breastfeeding

Donor Inclusion Criteria

  1. Age ≥ 18 years old
  2. HLA match with the recipient of at least 3/6. Donor may be the original transplant donor or a third party donor
  3. Consent to pre screening with PepTivator testing of T cell response to the relevant virus(es)
  4. Willing to undergo formal donor evaluation equivalent to that required for hematopoietic stem cell transplant (HSCT) donors
  5. Willing to consent to T cell processing under CHOP protocol CHP784 (IRB 04 004078) using the CliniMACS device

Donor Exclusion Criteria

  1. Donors younger than 18 years old
  2. HLA match with the recipient less than 3/6
  3. Refusal or inability to consent to PepTivator pre screening
  4. Unwillingness or inability to undergo formal donor evaluation (as required for HSCT donors)
  5. Refusal or inability to consent to T cell processing under The Children's Hospital of Philadelphia protocol (CHP784, IRB 04 004078) using the CliniMACS device
  6. Any medical, infectious, or other condition identified during evaluation that contraindicates donation per standard HSCT donor eligibility guidelines (e.g., active uncontrolled infection, significant cardiopulmonary disease, pregnancy) or that would preclude safe apheresis/T cell collection as determined by the evaluating clinicians.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Virus-Specific Cytotoxic T Lymphocytes (vCTLs)

    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

  • BiologicalVirus-Specific Cytotoxic T Lymphocytes (vCTLs)

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

  2. 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.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

Secondary outcomes

  1. Cytomegalovirus (CMV) Overall Response Rate

    This outcome measures the number of participants who achieve a virologic or clinical response following completion of vCTL therapy. Response categories include complete Response (undetectable viral load), partial Response (≥1-log reduction in viral load), mixed response (virologic or clinical improvement without both), stable disease (changes insufficient to qualify as a complete response, partial response or progression), and progressive disease (increase in viral load by quantitative polymerase chain reaction (qPCR) of at least 1-log from baseline). Viral load will be assessed by qPCR, and clinical symptoms will be evaluated by the study team.

    Time frame: Two weeks after the final vCTL infusion

  2. Adenovirus (ADV) Overall Response Rate

    This outcome measures the number of participants who achieve a virologic or clinical response following completion of vCTL therapy. Response categories include complete Response (undetectable viral load), partial Response (≥1-log reduction in viral load), mixed response (virologic or clinical improvement without both), stable disease (changes insufficient to qualify as a complete response, partial response or progression), and progressive disease (increase in viral load by quantitative polymerase chain reaction (qPCR) of at least 1-log from baseline). Viral load will be assessed by qPCR, and clinical symptoms will be evaluated by the study team.

    Time frame: Two weeks after the final vCTL infusion

  3. Epstein Barr Virus (EBV) Overall Response Rate

    This outcome measures the number of participants who achieve a virologic or clinical response following completion of vCTL therapy. Response categories include complete Response (undetectable viral load), partial Response (≥1-log reduction in viral load), mixed response (virologic or clinical improvement without both), stable disease (changes insufficient to qualify as a complete response, partial response or progression), and progressive disease (increase in viral load by quantitative polymerase chain reaction (qPCR) of at least 1-log from baseline). Viral load will be assessed by qPCR, and clinical symptoms will be evaluated by the study team.

    Time frame: Two weeks after the final vCTL infusion

  4. BK polyomavirus (BKV) Overall Response Rate

    This outcome measures the number of participants who achieve a virologic or clinical response following completion of vCTL therapy. Response categories include complete Response (undetectable viral load), partial Response (≥1-log reduction in viral load), mixed response (virologic or clinical improvement without both), stable disease (changes insufficient to qualify as a complete response, partial response or progression), and progressive disease (increase in viral load by quantitative polymerase chain reaction (qPCR) of at least 1-log from baseline). Viral load will be assessed by qPCR, and clinical symptoms will be evaluated by the study team.

    Time frame: Two weeks after the final vCTL infusion

  5. Cytomegalovirus (CMV) Overall Survival

    This outcome measures the length of time participants remain alive after receiving CMV vCTL therapy.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

  6. Adenovirus (ADV) Overall Survival

    This outcome measures the length of time participants remain alive after receiving ADV vCTL therapy.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

  7. Epstein Barr Virus (EBV) Overall Survival

    This outcome measures the length of time participants remain alive after receiving EBV vCTL therapy.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

  8. BK polyomavirus (BKV) Overall Survival

    This outcome measures the length of time participants remain alive after receiving BK vCTL therapy. Overall survival will be evaluated separately for participants treated for CMV, adenovirus, EBV, and BK virus infections.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

  9. Cytomegalovirus (CMV) Virus Free Survival

    This outcome measures the length of time participants remain alive and without detectable viral infection following vCTL therapy. Viral clearance will be assessed using quantitative PCR.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

  10. Adenovirus (ADV) Virus Free Survival

    This outcome measures the length of time participants remain alive and without detectable viral infection following vCTL therapy. Viral clearance will be assessed using quantitative PCR.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

  11. Epstein Barr Virus (EBV) Virus Free Survival

    This outcome measures the length of time participants remain alive and without detectable viral infection following vCTL therapy. Viral clearance will be assessed using quantitative PCR.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

  12. BK polyomavirus (BKV) Virus Free Survival

    This outcome measures the length of time participants remain alive and without detectable viral infection following vCTL therapy. Viral clearance will be assessed using quantitative PCR.

    Time frame: From first vCTL infusion (Day 0) through 12 weeks after the final vCTL infusion

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

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Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 2 updates
  1. Oct 22, 2026
    Minor edits only
    + 1 other change: secondary outcomes
  2. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873970
Lead sponsor
Children's Hospital of Philadelphia
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 2036 (estimated)
Completion
Nov 2037 (estimated)
Last update
Oct 22, 2026

Study contacts

Megan Atkinson
Contact
cttsbmtintake@chop.edu
215-590-2820
Kellie Patterson, BSN, RN
Contact
pattersok3@chop.edu
215-590-2820
Caitlin Elgarten, MD, MSCE
principal investigator · Children's Hospital of Philadelphia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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