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Graft vs Host DiseasePhase 1/2TREGenerationNCT02385019

A Phase 1/2 Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease

A Phase 1/2 study testing Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease in people with Graft vs Host Disease, run by Instituto de Medicina Molecular João Lobo Antunes at 3 sites in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host disease after an allogeneic transplant of hematopoietic progenitors with donor CliniMACS-selected regulatory T cells Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Graft vs Host Disease
What is being tested?
Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
3 sitesPortugal
Study dates
Mar 2015to Dec 2019
Phase
Phase 1/2
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients must have persistent signs and symptoms despite the use of prednisone or equivalent at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day), for at least 4 weeks without complete resolution of signs and symptoms. Occasional patients requiring lower doses of prednisone will be eligible if associated with other immunosuppressive drugs.
  • Stable immunosuppressive medication in the 4 weeks prior to initiation of treatment
  • PS 0-2 ECOG
  • Adequate liver, kidney, lung and hematopoietic system functions

Who cannot join

  • Pediatric patients
  • Pregnant women
  • Ongoing prednisone requirement >1 mg/kg/day (or equivalent)
  • Concurrent use of calcineurin-inhibitor plus sirolimus (either agent alone is acceptable)
  • New immunosuppressive medication in the 4 weeks prior
  • Extra-corporeal Photopheresis or rituximab therapy in the 4 weeks prior
Show all 11Show fewer
  • Exposure to T-cell or IL-2 targeted medication (e.g. ATG, alemtuzumab, basiliximab, denileukin diftitox) within 100 days prior
  • Donor lymphocyte infusion within 100 days prior
  • Active malignant relapse
  • Active uncontrolled infection
  • HIV-infected patients

Trial locations and contacts

3 sites in 1 country.

Portugal3 sites, 3 recruiting

  • Instituto Portugues de Oncologia

    Lisbon, 1099-023

    Isabelina Ferreira, MD, +351917502335, iferreira@ipolisboa.min-saude.pt

    Recruiting

  • Hospital de Santa Maria, Faculdade de Medicina da Universidade de Lisboa, Instituto de Medicina Molecular

    Lisbon, 1649-028

    Joao F Lacerda, MD PhD, +351919727656, jlacerda@fm.ul.pt

    Recruiting

  • Instituto Portugues de Oncologia

    Porto, 4200-072

    Carlos Pinho Vaz, MD, +351968014520, cpvaz@ipoporto.min-saude.pt

    Recruiting

Other trials in Portugal

About this study

Phase 1/2 clinical study for the treatment of steroid-refractory chronic graft versus host disease after an allogeneic transplant of hematopoietic progenitors with donor CliniMACS-selected regulatory T cells

Read the detailed description

Phase 1/2 clinical study evaluating safety (Phase 1) and preliminary efficacy (Phase 2) of donor regulatory T cells for patients with steroid-refractory chronic graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT).

Patients must have persistent signs and symptoms despite the use of prednisone or equivalent at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day), for at least 4 weeks without complete resolution of signs and symptoms. Occasional patients requiring lower doses of prednisone will be eligible if associated with other immunosuppressive drugs.

Phase 1 clinical trial will include groups of 5 patients sequentially treated with: 0.5 x 10ˆ6, 1.0 x 10ˆ6, 2-3 x 10ˆ6 donor Treg/kg. Phase 2 clinical trial will include another 5 to 10 patients treated with MTD.

Donor Treg will be selected by the following sequential steps:

  1. - negative depletion of CD8 and CD19 cells
  2. - positive selection of CD25 cells
Being tested
Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease
Keywords
Allogeneic hematopoietic stem cell transplantation, Graft vs host disease, Regulatory T cells
Medical subject headings
Graft vs Host Disease

What participants receive

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

  • Donor regulatory T cell adoptive immunotherapy in chronic graft versus host diseaseBiological

    Regulatory T cells selected by a sequential 2 step procedure:

    1. - Negative selection of CD8 and CD19 cells
    2. - Positive selection of CD25 cells
Study groups in NCT02385019
Study groupRoleWhat they receive
Administration of 0.5 x 10ˆ6 donor Treg/kgExperimentalFirst group of 5 patients will receive a total of 0.5 x 10ˆ6 donor Treg/kg. Part of Phase 1 study.
Receives: Biological: Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease
Administration of 1.0 x 10ˆ6 donor Treg/kgExperimentalSecond group of 5 patients will receive a total of 1.0 x 10ˆ6 donor Treg/kg. Part of Phase 1 study.
Receives: Biological: Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease
Administration of 2.0-3.0 x 10ˆ6 donor Treg/kgExperimentalThird group of 5 patients will receive a total of 2.0-3.0 x 10ˆ6 donor Treg/kg. Part of Phase 1 study.
Receives: Biological: Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease
Administration of MTD of donor T regExperimentalPreliminary Phase 2 study will include another 5 to 10 patients at the MTD identified in the Phase 1 study
Receives: Biological: Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease

What is being measured

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

  1. Progression of graft versus host disease according to the 2014 NIH consensus criteria and myelosuppression after the administration of 3 doses of donor regulatory T cells / kg recipient's body weight: 0.5 x 10ˆ6, 1.0 x 10ˆ6 and 2.0-3.0 x 10ˆ6 cells

    Progression of graft versus host disease and myelosuppression are indicators of toxicity and MTD associated with the infusion of donor regulatory T cells

    Measured: Response evaluated 12 weeks after infusion

Secondary outcomes (3)

  1. Chronic graft versus host disease improvement according to the 2014 NIH consensus criteria following the infusion of donor regulatory T cells

    Measured: Response evaluated 12 weeks after infusion

  2. Total lymphocyte, CD4, CD8 and regulatory T cell counts after the infusion of donor regulatory T cells for the treatment of chronic graft versus host disease

    Measured: Response evaluated 12 weeks after infusion

  3. Survival at 1 year after administration of donor regulatory T cells in patients with chronic graft versus host disease

    Measured: Response evaluated 12 months after infusion

Timeline

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

  1. First posted11 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2019 (estimated)
  4. Study completionDec 2019 (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
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02385019
Sponsor's protocol ID
TREGeneration-Portugal
Acronym
TREGeneration
Status last verified
Mar 2018
First submitted
1 Mar 2015
Last updated
6 Mar 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Soares MVD, Gomez VE, Azevedo RI, Pereira PNG, Velazquez TC, Mendes L, Alho AC, Garcia-Guerrero E, Garcia-Calderon CB, Tharmaratnam K, Cabral IA, Ribeiro AC, Juncal C, Roncon S, Pais AT, Gil AR, Espada E, Rodrigues A, Garcao A, Yaspo ML, Warnatz HJ, Lehrach H, Ward L, Barbosa-Morais NL, Quintas AM, Palmela P, Caldas C, Ferreira R, Leite L, Martins C, Lourenco F, Moreno R, Campilho F, Cheyne CP, Garcia-Finana M, Campos A, Baron F, Arpinati M, Hoffmann P, Edinger M, Koreth J, Ritz J, Vaz CP, Perez-Simon JA, Lacerda JF. Phase 1/2 trials of donor regulatory T cells for the treatment of steroid-refractory chronic graft-versus-host disease. Blood Adv. 2026 May 12;10(9):2904-2915. doi: 10.1182/bloodadvances.2025017996.

    PubMed 41637631

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease in people with Graft vs Host Disease, run by Instituto de Medicina Molecular João Lobo Antunes at 3 sites in Portugal.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Portugal. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression of graft versus host disease according to the 2014 NIH consensus criteria and myelosuppression after the administration of 3 doses of donor regulatory T cells / kg recipient's body weight: 0.5 x 10ˆ6, 1.0 x 10ˆ6 and 2.0-3.0 x 10ˆ6 cells (time frame: Response evaluated 12 weeks after infusion). 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 NCT02385019, which also lists 1 linked publication.

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 6 Mar 2018.

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