Extranodal NK/T-cell LymphomaPhase 3NCT05700448
Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma
A Phase 3 study testing Sugemalimab, Pegaspargase and Gemcitabine in people with Extranodal NK/T-cell Lymphoma, run by CStone Pharmaceuticals.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma
- What is being tested?
- Sugemalimab, Pegaspargase and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to Dec 2030
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has ENKTL histologically confirmed by the study center. Nasal and non-nasal ENKTL are both allowed.
- Has relapsed or refractory ENKTL after prior asparaginase-based chemotherapy or chemoradiotherapy.
- Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Has at least one measurable lesion per Lugano 2014 classification.
- Is willing to provide stained tumor tissue sections and corresponding pathological reports or unstained tumor tissue sections (or tissue block) for central pathology review.
- Has adequate organ function.
- Has life expectancy of greater than 3 months.
Who cannot join
- Has aggressive natural killer-cell leukemia, current central nervous system (CNS) involvement or is concomitant with hemophagocytic lymphohistiocytosis.
- Has known additional malignancy within 5 years prior to randomization.
- Has an active autoimmune disease or has had an autoimmune disease that may relapse.
- Has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment.
- Has active tuberculosis infection.
- Has a known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome (AIDS).
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- Has a known active Hepatitis B or C virus infection.
- Has received systemic anti-cancer therapy within 28 days before the first dose of study treatment, including chemotherapy, immunotherapy, biological therapy (e.g. cancer vaccine, cytokine therapy or growth factors to treat cancer).
- Has used traditional Chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of study treatment.
- Has received systemic corticosteroid or any other immunosuppressive therapy within 14 days before the first dose of study treatment.
- Has received any treatment of antibody or drug that targets at T-cell coregulatory pathways or immune checkpoint pathways.
- Has toxicity from prior anti-cancer treatment, except for alopecia and fatigue, that has not recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 before the first dose of study treatment.
- Has had allogenic hematopoietic stem cell transplantation (HSCT) within 5 years or autologous HSCT within 90 days before the first dose of study treatment.
- Has a known severe hypersensitivity to sugemalimab, its active substance and/or any of its excipients, or to other monoclonal antibodies.
- Female participants who are pregnant or breastfeeding.
- Is currently participating in or has participated in a trial of an investigational agent within 28 days before to the first dose of study treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)
The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.
- Conditions
- Extranodal NK/T-cell Lymphoma
- Being tested
- Sugemalimab, Placebo, Pegaspargase, Gemcitabine, Oxaliplatin
- 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.
SugemalimabBiological
IV infusion
PlaceboDrug
IV infusion
PegaspargaseDrug
Intramuscular injection
GemcitabineDrug
IV infusion
OxaliplatinDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Sugemalimab+PGemOx | Experimental | Participants receive sugemalimab 1200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 \& 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1. Receives: Biological: Sugemalimab; Drug: Pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin |
| Placebo+PGemOx | Placebo comparator | Participants receive placebo via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 \& 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1. Receives: Drug: Placebo; Drug: Pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: Approximately 39 months after First Patient In
Secondary outcomes (4)
Overall survival (OS)
Measured: Approximately 39 months after First Patient In
Progression-free survival (PFS) evaluated by the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: Approximately 39 months after First Patient In
Objective response rate (ORR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: Approximately 39 months after First Patient In
Duration of response (DoR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Measured: Approximately 39 months after First Patient In
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study startJun 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (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 LymphomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinzhou Qi, Study director, CStone Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700448
- Sponsor's protocol ID
- CS1001-306
- Status last verified
- May 2026
- First submitted
- 17 Jan 2023
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)
- ClinicalTrials.gov ID
- NCT05700448
- Acronym / sponsor ID
- CS1001-306
- Conditions
- Extranodal NK/T-cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Jan 2023 (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.
The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugemalimab+PGemOx | Experimental | Biological: Sugemalimab, Drug: Pegaspargase, Drug: Gemcitabine, Drug: OxaliplatinParticipants receive sugemalimab 1200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 \& 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1. |
| Placebo+PGemOx | Placebo comparator | Drug: Placebo, Drug: Pegaspargase, Drug: Gemcitabine, Drug: OxaliplatinParticipants receive placebo via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS PGemOx regimen Q3W (pegaspargase 2000-2500 IU/m^2 via intramuscular injection on Day 1, gemcitabine 1000 mg/m^2 via IV infusion on Days 1 \& 8 and oxaliplatin 130 mg/m^2 via IV infusion on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has ENKTL histologically confirmed by the study center. Nasal and non-nasal ENKTL are both allowed.
- Has relapsed or refractory ENKTL after prior asparaginase-based chemotherapy or chemoradiotherapy.
- Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Has at least one measurable lesion per Lugano 2014 classification.
- Is willing to provide stained tumor tissue sections and corresponding pathological reports or unstained tumor tissue sections (or tissue block) for central pathology review.
Key exclusion criteria (16 listed)
- Has aggressive natural killer-cell leukemia, current central nervous system (CNS) involvement or is concomitant with hemophagocytic lymphohistiocytosis.
- Has known additional malignancy within 5 years prior to randomization.
- Has an active autoimmune disease or has had an autoimmune disease that may relapse.
- Has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment.
- Has active tuberculosis infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugemalimabIV infusion | Biological | Sugemalimab+PGemOx |
| PlaceboIV infusion | Drug | Placebo+PGemOx |
| PegaspargaseIntramuscular injection | Drug | Placebo+PGemOx, Sugemalimab+PGemOx |
| GemcitabineIV infusion | Drug | Placebo+PGemOx, Sugemalimab+PGemOx |
| OxaliplatinIV infusion | Drug | Placebo+PGemOx, Sugemalimab+PGemOx |
Primary outcome
Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: Approximately 39 months after First Patient In
4 secondary outcomes
Overall survival (OS)
Time frame: Approximately 39 months after First Patient In
Progression-free survival (PFS) evaluated by the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: Approximately 39 months after First Patient In
Objective response rate (ORR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: Approximately 39 months after First Patient In
Duration of response (DoR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: Approximately 39 months after First Patient In
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 27 May 2026.
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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.
Qinzhou Qi study director
CStone Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sugemalimab, Pegaspargase and Gemcitabine in people with Extranodal NK/T-cell Lymphoma, run by CStone Pharmaceuticals.
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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Wenyun Zhang (+86 021-60333416, cstoneRA@cstonepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification (time frame: Approximately 39 months after First Patient In). 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 27 May 2026.