Extranodal NK/T-cell Lymphoma, Nasal TypeNCT07920757
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
An observational study of Extranodal NK/T-cell Lymphoma, Nasal Type, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
This retrospective observational study characterises the tumour immune microenvironment and clonal architecture of relapsed or refractory extranodal NK/T-cell lymphoma (ENKTCL). Archival tumour tissue and blood samples collected during routine care are profiled by single-cell RNA sequencing, T-cell and B-cell receptor… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Nasal Type
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2022to 31 Dec 2028
- Phase
- Observational
- 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
Study population: Patients with extranodal NK/T-cell lymphoma treated at Fujian Medical University Union Hospital, China, whose archival tumour tissue and peripheral blood samples are available for molecular profiling.
Who may be able to join
- Histologically confirmed extranodal NK/T-cell lymphoma, nasal type
- Relapsed or refractory disease after at least one prior line of therapy, or archival tissue available from a relapse episode
- Archival formalin-fixed paraffin-embedded tumour tissue and/or peripheral blood available for molecular profiling
- Received PD-1 or PD-L1 blockade as part of routine care at any point in the disease course
- Written informed consent for the use of residual clinical specimens in research, or a waiver of additional consent granted by the institutional ethics committee
Who cannot join
- Insufficient tissue or nucleic acid quality for the planned profiling assays
- Incomplete clinical records precluding assessment of response or outcome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Study of Tumour Microenvironment Remodelling and Clonal Architecture in Relapsed or Refractory Extranodal NK/T-cell Lymphoma Using Single-Cell, Spatial and Genomic Profiling
This retrospective observational study characterises the tumour immune microenvironment and clonal architecture of relapsed or refractory extranodal NK/T-cell lymphoma (ENKTCL). Archival tumour tissue and blood samples collected during routine care are profiled by single-cell RNA sequencing, T-cell and B-cell receptor repertoire sequencing, whole-exome sequencing, and spatial transcriptomics. The study examines how immune and stromal cell states, clonal composition and spatial organisation relate to response to programmed cell death protein 1 (PD-1) blockade and to subsequent relapse.
Read the detailed description
Extranodal NK/T-cell lymphoma is an Epstein-Barr virus (EBV)-associated lymphoma with a high relapse rate and few validated molecular predictors of response to immune checkpoint blockade. In this retrospective study, we assemble a cohort of patients with relapsed or refractory ENKTCL treated at a single centre, with a planned total of up to 50 patients, together with available pre- and post-treatment tumour tissue and peripheral blood. Samples are analysed by single-cell RNA sequencing with paired T-cell receptor (TCR) and B-cell receptor (BCR) repertoire sequencing, whole-exome sequencing, multiplex imaging, and spatial transcriptomics where tissue permits. We characterise the composition and transcriptional states of immune and stromal populations, the genomic landscape including chromosome 6q loss, the relationship between clonal architecture and spatial organisation, and the association of these features with response to PD-1 blockade and with relapse patterns. Analyses are descriptive and hypothesis-generating; no intervention, treatment assignment or change in clinical care is involved. All analyses are covered by approvals from the Ethics Committee of Fujian Medical University Union Hospital (2022WSJK019, approved 27 September 2022; 2023KY146, approved 22 August 2023).
- Keywords
- extranodal NK/T-cell lymphoma, single-cell RNA sequencing, spatial transcriptomics, whole-exome sequencing, tumour immune microenvironment, PD-1 blockade
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Responders to PD-1 blockade | Patients who achieved an objective response to PD-1 or PD-L1 blockade, from whom pre- and post-treatment tumour tissue and peripheral blood were profiled. | |
| Non-responders to PD-1 blockade | Patients who did not achieve an objective response to PD-1 or PD-L1 blockade, from whom pre- and post-treatment tumour tissue and peripheral blood were profiled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition and transcriptional states of immune and stromal cell populations in ENKTCL tumour tissue
Cell-type composition, activation and exhaustion states of T, NK, B and myeloid populations and of stromal subsets, determined by single-cell RNA sequencing of tumour tissue.
Measured: Baseline (pre-treatment) and relapse (up to 36 months after diagnosis); assessed retrospectively
Clonal architecture of T-cell and B-cell receptor repertoires
Clonal diversity and the distribution of expanded clones across transcriptional cell states, determined by paired T-cell and B-cell receptor repertoire sequencing.
Measured: Baseline and relapse (up to 36 months after diagnosis); assessed retrospectively
Secondary outcomes (4)
Somatic genomic alterations, including chromosome 6q copy-number loss
Somatic mutations and copy-number alterations determined by whole-exome sequencing of tumour tissue.
Measured: Baseline, assessed retrospectively
Spatial organisation of tumour and immune compartments
Spatial distribution of malignant, immune and stromal compartments in archival tissue, determined by spatial transcriptomics and multiplex imaging.
Measured: Baseline and relapse (up to 36 months after diagnosis); assessed retrospectively
Correlation of baseline immune and stromal features with response to PD-1 or PD-L1 blockade
Correlation between baseline immune and stromal features in tumour tissue, expressed as the percentage of cluster of differentiation 8 (CD8)-positive T cells, NK cells, B cells and plasma cells among all cells and as their spatial density (cells per mm2), measured by single-cell RNA sequencing and spatial transcriptomics; and objective response to PD-1 or PD-L1 blockade, expressed as the percentage of patients achieving a complete or partial response by RECIST 1.1 or LYRIC criteria.
Measured: Baseline (pre-treatment) through study completion, an average of 36 months
Correlation of baseline immune and stromal features with relapse site and pattern
Correlation between baseline immune and stromal features in tumour tissue, expressed as the percentage of T cells, NK cells, B cells and plasma cells among all cells, measured by single-cell RNA sequencing; and relapse site and pattern, expressed as the percentage of patients with local, regional or distant relapse classified from imaging and clinical records.
Measured: Baseline (pre-treatment) through study completion, an average of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start27 Sep 2022
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell Lymphoma, Nasal TypeStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Yang, Fujian Medical University Union Hospital
- Investigators
- Yong Yang, MD, PhD, Principal investigator, Fujian Medical University Union HospitalJian Liu (jianliu@nankai.edu.cn), PhD, Study director, Nankai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920757
- Sponsor's protocol ID
- FJMUUH-ENKTCL-MO-2022-01
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data, including clinical records and sample-level identifiers, will not be shared. De-identified sequencing and spatial transcriptomic data will be deposited in the Genome Sequence Archive for Human (GSA-Human), National Genomics Data Center, China, and will be made available for research use through the repository according to its access policy after publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study of Tumour Microenvironment Remodelling and Clonal Architecture in Relapsed or Refractory Extranodal NK/T-cell Lymphoma Using Single-Cell, Spatial and Genomic Profiling
- ClinicalTrials.gov ID
- NCT07920757
- Acronym / sponsor ID
- FJMUUH-ENKTCL-MO-2022-01
- Keywords
- extranodal NK/T-cell lymphoma, single-cell RNA sequencing, spatial transcriptomics, whole-exome sequencing, tumour immune microenvironment, PD-1 blockade
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective observational study characterises the tumour immune microenvironment and clonal architecture of relapsed or refractory extranodal NK/T-cell lymphoma (ENKTCL). Archival tumour tissue and blood samples collected during routine care are profiled by single-cell RNA sequencing, T-cell and B-cell receptor repertoire sequencing, whole-exome sequencing, and spatial transcriptomics. The study examines how immune and stromal cell states, clonal composition and spatial organisation relate to response to programmed cell death protein 1 (PD-1) blockade and to subsequent relapse.
Detailed description
Extranodal NK/T-cell lymphoma is an Epstein-Barr virus (EBV)-associated lymphoma with a high relapse rate and few validated molecular predictors of response to immune checkpoint blockade. In this retrospective study, we assemble a cohort of patients with relapsed or refractory ENKTCL treated at a single centre, with a planned total of up to 50 patients, together with available pre- and post-treatment tumour tissue and peripheral blood. Samples are analysed by single-cell RNA sequencing with paired T-cell receptor (TCR) and B-cell receptor (BCR) repertoire sequencing, whole-exome sequencing, multiplex imaging, and spatial transcriptomics where tissue permits. We characterise the composition and transcriptional states of immune and stromal populations, the genomic landscape including chromosome 6q loss, the relationship between clonal architecture and spatial organisation, and the association of these features with response to PD-1 blockade and with relapse patterns. Analyses are descriptive and hypothesis-generating; no intervention, treatment assignment or change in clinical care is involved. All analyses are covered by approvals from the Ethics Committee of Fujian Medical University Union Hospital (2022WSJK019, approved 27 September 2022; 2023KY146, approved 22 August 2023).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responders to PD-1 blockade | – | –Patients who achieved an objective response to PD-1 or PD-L1 blockade, from whom pre- and post-treatment tumour tissue and peripheral blood were profiled. |
| Non-responders to PD-1 blockade | – | –Patients who did not achieve an objective response to PD-1 or PD-L1 blockade, from whom pre- and post-treatment tumour tissue and peripheral blood were profiled. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with extranodal NK/T-cell lymphoma treated at Fujian Medical University Union Hospital, China, whose archival tumour tissue and peripheral blood samples are available for molecular profiling.
Key inclusion criteria (5 listed)
- Histologically confirmed extranodal NK/T-cell lymphoma, nasal type
- Relapsed or refractory disease after at least one prior line of therapy, or archival tissue available from a relapse episode
- Archival formalin-fixed paraffin-embedded tumour tissue and/or peripheral blood available for molecular profiling
- Received PD-1 or PD-L1 blockade as part of routine care at any point in the disease course
- Written informed consent for the use of residual clinical specimens in research, or a waiver of additional consent granted by the institutional ethics committee
Key exclusion criteria (2 listed)
- Insufficient tissue or nucleic acid quality for the planned profiling assays
- Incomplete clinical records precluding assessment of response or outcome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composition and transcriptional states of immune and stromal cell populations in ENKTCL tumour tissue
Time frame: Baseline (pre-treatment) and relapse (up to 36 months after diagnosis); assessed retrospectively
Cell-type composition, activation and exhaustion states of T, NK, B and myeloid populations and of stromal subsets, determined by single-cell RNA sequencing of tumour tissue.
Clonal architecture of T-cell and B-cell receptor repertoires
Time frame: Baseline and relapse (up to 36 months after diagnosis); assessed retrospectively
Clonal diversity and the distribution of expanded clones across transcriptional cell states, determined by paired T-cell and B-cell receptor repertoire sequencing.
4 secondary outcomes
Somatic genomic alterations, including chromosome 6q copy-number loss
Time frame: Baseline, assessed retrospectively
Spatial organisation of tumour and immune compartments
Time frame: Baseline and relapse (up to 36 months after diagnosis); assessed retrospectively
Correlation of baseline immune and stromal features with response to PD-1 or PD-L1 blockade
Time frame: Baseline (pre-treatment) through study completion, an average of 36 months
Correlation of baseline immune and stromal features with relapse site and pattern
Time frame: Baseline (pre-treatment) through study completion, an average of 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data, including clinical records and sample-level identifiers, will not be shared. De-identified sequencing and spatial transcriptomic data will be deposited in the Genome Sequence Archive for Human (GSA-Human), National Genomics Data Center, China, and will be made available for research use through the repository according to its access policy after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Yang, MD, PhD principal investigator
Fujian Medical University Union Hospital
Jian Liu (jianliu@nankai.edu.cn), PhD study director
Nankai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extranodal NK/T-cell Lymphoma, Nasal Type, run by Fujian Medical University Union Hospital at 1 site in China.
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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition and transcriptional states of immune and stromal cell populations in ENKTCL tumour tissue (time frame: Baseline (pre-treatment) and relapse (up to 36 months after diagnosis); assessed retrospectively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.