ClinicalTrials.gg
Active, not recruitingNCT07920757Updated Nov 6, 2026

Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma

An observational study in Extranodal NK/T-cell Lymphoma, Nasal Type, sponsored by Fujian Medical University Union Hospital. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Fujian Medical University Union Hospital · Observational

Updated Nov 6, 2026Newly registeredGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 73 studies in Lymphoma, Extranodal NK-T-Cell with a site in China — 22 open to participants now, 25 under way, 2 of them phase 3. Lymphoma, Extranodal NK-T-Cell · China.

Started
2022
with 3 others
Observational
7 of 73
5 open now
Primary completion
2028-12
later than 18 of 24 live
Registered
73rd of 73
by date

Among the 73 studies in Lymphoma, Extranodal NK-T-Cell with a site in China, this one is one of 4 that started in 2022, is one of 7 observational ones, reaches primary completion later than 18 of the 24 other live ones, and was the 73rd registered.

Lymphoma, Extranodal NK-T-Cell

270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.

Browse Lymphoma, Extranodal NK-T-Cell studies →

Open to participants now

22 of the 73 studies in Lymphoma, Extranodal NK-T-Cell with a site in China are open now. Recruiting first, the newest first:

17 more — sign in →

All 22 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 20 Lymphoma, Extranodal NK-T-Cell studies recruiting now, 11 (55%) set no upper age limit and 8 (40%) stop at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study 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 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).

03

Conditions studied

  • Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

  • extranodal NK/T-cell lymphoma
  • single-cell RNA sequencing
  • spatial transcriptomics
  • whole-exome sequencing
  • tumour immune microenvironment
  • PD-1 blockade
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed extranodal NK/T-cell lymphoma, nasal type
  • disease after at least one , or available from a relapse episode
  • Archival formalin-fixed paraffin-embedded tumour tissue and/or peripheral blood available for molecular profiling
  • Received or PD-L1 blockade as part of routine care at any point in the disease course
  • Written for the use of residual clinical specimens in research, or a waiver of additional consent granted by the institutional ethics committee

Exclusion criteria

Exclusion Criteria:

  • Insufficient tissue or nucleic acid quality for the planned profiling assays
  • Incomplete clinical records precluding assessment of response or outcome
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (pre-treatment) and relapse (up to 36 months after diagnosis); assessed retrospectively

  2. 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.

    Time frame: Baseline and relapse (up to 36 months after diagnosis); assessed retrospectively

Secondary outcomes

  1. Somatic genomic alterations, including chromosome 6q copy-number loss

    Somatic mutations and copy-number alterations determined by whole-exome sequencing of tumour tissue.

    Time frame: Baseline, assessed retrospectively

  2. 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.

    Time frame: Baseline and relapse (up to 36 months after diagnosis); assessed retrospectively

  3. 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.

    Time frame: Baseline (pre-treatment) through study completion, an average of 36 months

  4. 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.

    Time frame: Baseline (pre-treatment) through study completion, an average of 36 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2022 (actual). Primary completion is estimated for Dec 2028, 75 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 6, 2026
StartActual
Sep 27, 2022
Primary completionEst.
Dec 30, 2028
CompletionEst.
Dec 31, 2028
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 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
NCT07920757
Responsible party
Yong Yang (Principal Investigator, Fujian Medical University Union Hospital) — Principal investigator
First posted
Nov 6, 2026
Start date
Sep 27, 2022
Primary completion
Dec 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Yong Yang, MD, PhD
principal investigator · Fujian Medical University Union Hospital
Jian Liu (jianliu@nankai.edu.cn), PhD
study director · Nankai University

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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