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AzTrials

EBV LymphomaPhase 1/2ESPECTNCT05688241

EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases

A Phase 1/2 study testing Donor-derived ex-vivo expanded EBV Tscm CTL in people with EBV Lymphoma and Post-transplant Lymphoproliferative Disease (PTLD), run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In this multi-center open-label, non-randomized phase I/II intervention study three consecutive doses of donor-derived EBV Tscm-CTLs will be administered to 10 patients with treatment-refractory EBV lymphoma, diseases or PTLDs. EBV Tscm-CTLs will derive from hematopoietic cell transplant (HCT) or third-party donors. Read more about this study

Who is it for?
Any age
What is being tested?
Donor-derived ex-vivo expanded EBV Tscm CTL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
8 sitesSwitzerland
Study dates
Nov 2026to Dec 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Patients' inclusion criteria:

  • Group A: Patients with EBV driven lymphomas (e.g., NK/T-cell lymphoma), with EBV complications (e.g. HLH, CAEBV) or patients with primary immunodeficiency disorders with high risk for EBV complications (e.g. SCID) with planned allogeneic HCT
  • Group B: EBV-driven PTLD that develop after a HCT or SOT

For both groups:

  • All age groups
  • Negative pregnancy test in female patients of childbearing potential.
  • Signed written informed consent of patient or/and parents

Patients' exclusion criteria:

  • Patients receiving anti-thymocyte globulin or Campath within 28 days of infusion
  • Patients with active, acute GvHD grades III-IV
  • Previous severe reaction to dimethylsulfoxide (DMSO)

Donors' inclusion criteria:

  • EBV positive serology (VCA and Epstein-Barr nuclear antigen (EBNA) immunoglobulin G (IgG) positive)
  • Detectable interferon (IFN)-y-secreting T cells (>100 SFC/10e6 PBMC) measured by Elispot to the EBV consensus peptide pool
  • Suitability for blood or HCT donation meeting requirements of local institutional guidelines
  • An informed consent for EBV Tscm CTL manufacturing
  • Age > 18 years

Donors' exclusion criteria:

  • Detectable IFN-y-secreting T-cells <100 spot-forming cell (SFC)/10e6 PBMC measured by Elispot to EBV select
  • Unwilling and/or unable to donate, according to the donor center

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nina Khanna, Prof. Dr. med. contact

+41 61 328 73 25

nina.khanna@usb.ch

8 sites in 1 country

Switzerland8 sites

  • University Hospital Basel, Klinik für Infektiologie und Spitalhygiene

    Basel, 4031

    Nina Khanna, Prof. Dr. med., +41 61 328 73 25, nina.khanna@usb.ch

    Nina Khanna, Prof. Dr. med.

  • Universitäts-Kinderspital beider Basel (UKBB)

    Basel, 4056

    Tamara Diesch- Furlanetto, Dr. med.

    Tamara Diesch- Furlanetto, Dr. med.

  • Universitätsspital Bern, Klinik für Infektiologie

    Bern, 3010

    Urban Novak, Prof. Dr. med.

    Urban Novak, Prof. Dr. med.

  • Hôpitaux Universitaires de Genève, Hôpital des Enfants

    Geneva, 1205

    Marc Ansari, Prof. Dr. med.

    Marc Ansari, Prof. Dr. med.

  • Hôpitaux Universitaires de Genève, Service d'Hématologie

    Geneva, 1211

    Yves Chalandon, Prof. Dr. med.

    Yves Chalandon, Prof. Dr. med.

  • Centre hospitalier universitaire vaudois, Service et Laboratoire central d'hématologie

    Lausanne, 1011

    Michel Duchosal, Prof. Dr. med.

    Michel Duchosal, Prof. Dr. med.

  • Kinderspital Zürich

    Zurich, 8032

    Tayfun Güngör, Prof. Dr. med.

    Tayfun Güngör, Prof. Dr. med.

  • University Hospital Zurich, Hämatologie

    Zurich, 8091

    Dominik Schneidawind, PD Dr. med.

    Nathan Wolfensberger, Dr. med.

Other trials in Switzerland

About this study

Official title: Epstein-Barr Virus (EBV) -Specific T Memory Stem Cell (Tscm) Therapy to Treat EBV- Driven Lymphomas/ Diseases

In this multi-center open-label, non-randomized phase I/II intervention study three consecutive doses of donor-derived EBV Tscm-CTLs will be administered to 10 patients with treatment-refractory EBV lymphoma, diseases or PTLDs. EBV Tscm-CTLs will derive from hematopoietic cell transplant (HCT) or third-party donors.

Read the detailed description

Epstein Barr virus (EBV)-driven lymphomas and diseases are associated with poor prognosis. EBV proteins are recognized by T cells providing opportunities for EBV-specific T-cell therapy. Recent findings show that early differentiated T cells (T memory stem cells, Tscm) improve the prognosis in chronic viral diseases and are associated with effective tumor cell killing in melanoma patients. Tscm might be superior to highly differentiated T cells because of their longevity, robust proliferative potential, and capacity to reconstitute a wide T-cell receptor (TCR) diversity. This project will test the hypothesis that Tscm are efficacious for EBV-specific T-cell therapy. Clinical-grade enriched EBV-specific Tscm-CTLs will be prepared and used to treat patients with primary EBV lymphomas, diseases or post-transplant lymphoproliferative disease (PTLD) with limited other treatment options.

Being tested
Donor-derived ex-vivo expanded EBV Tscm CTL
Keywords
EBV-driven Lymphomas, EBV disease, Epstein-Barr Virus (EBV), Memory Stem Cell Therapy, Epstein-Barr Virus-specific T Memory Stem Cell Therapy (EBV-Tscm), cytotoxic T-cell line (CTL), T memory stem cells (Tscm), T-cell receptor (TCR), post-transplant lymphoproliferative disease (PTLD), Wnt-β-catenin inhibition, hematopoietic cell transplantation (HCT), Hematopoietic stem cell transplantation (HSCT)
Medical subject headings
Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Donor-derived ex-vivo expanded EBV Tscm CTLDrug

    Cryopreserved cells will be thawed and infused at three time points. Dosing will be 2x10e6 EBV CTLs per kg of body weight. No prior lymphodepletion will be performed.

Study groups in NCT05688241
Study groupRoleWhat they receive
Group A: patients who undergo allogeneic HCTExperimentalPatients with EBV driven lymphomas (e.g., natural killer (NK)/T-cell lymphoma), with EBV complications (e.g. haemophagocytic lymphohistiocytosis (HLH), CAEBV) or patients with primary immunodeficiency disorders with high risk for EBV complications (e.g. SCID) with planned allogeneic HCT.
Receives: Drug: Donor-derived ex-vivo expanded EBV Tscm CTL
Group B: patients after HCT or SOTExperimentalEBV-driven PTLD that develop after a HCT or solid organ transplantation (SOT) and show decreased response to rituximab.
Receives: Drug: Donor-derived ex-vivo expanded EBV Tscm CTL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of feasibility to expand Tscm-enriched EBV CTLs

    Feasibility is defined as meeting the release criteria of EBV Tscm-CTL endproduct.

    Release criteria for the EBV Tscm-CTL follow Swissmedic Investigational Medicinal Product Dossier (IMPD). This includes viability of cluster of differentiation 3 (CD3)+ >70%, absolute CD3 count per kg of body weight per dose (≤2x10e6/kg), and a purity of CD3+ >90%. These criteria will be assessed before cryopreservation. A negative culture for bacteria and fungi for at least 7 days, endotoxin testing ≤5 EU/ml and negative result for Mycoplasma is required.

    Measured: one time assessment on day 9-11 of expansion before cryopreservation (plus at least 7 days for microbiological culture)

  2. Safety of EBV Tscm-CTL infusion assessed by number of early infusion-related events

    Number of early infusion-related events (early infusion-related events are clinically significant alterations of vital signs)

    Measured: up to 12 hours after first dose of EBV Tscm-CTL infusion

  3. Safety of EBV Tscm-CTL infusion assessed by number of late clinical reaction to EBV Tscm-CTLs

    Late clinical reaction to EBV Tscm-CTLs are signs of acute graft-versus-host disease (GvHD). Acute GVHD will be graded according to the modified Glucksberg criteria.

    Measured: from 12 hours after first dose until 3 months after the last dose of EBV CTLs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study startNov 2026 (estimated)
  3. Primary completionDec 2031 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Multi-center open-label, non-randomized phase I/II study.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05688241
Sponsor's protocol ID
2022-01210; am22Khanna
Acronym
ESPECT
Status last verified
Feb 2025
First submitted
21 Dec 2022
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Donor-derived ex-vivo expanded EBV Tscm CTL in people with EBV Lymphoma and Post-transplant Lymphoproliferative Disease (PTLD), run by University Hospital, Basel, Switzerland at 8 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nina Khanna, Prof. Dr. med. (+41 61 328 73 25, nina.khanna@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of feasibility to expand Tscm-enriched EBV CTLs (time frame: one time assessment on day 9-11 of expansion before cryopreservation (plus at least 7 days for microbiological culture)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05688241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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