NCT05700448

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
43mo left

Started Jun 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
3.3 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

January 17, 2023

Last Update Submit

February 4, 2026

Conditions

Extranodal NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

    Approximately 39 months after First Patient In

Secondary Outcomes (4)

  • Overall survival (OS)

    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

    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

    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

    Approximately 39 months after First Patient In

Study Arms (2)

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.

Biological: SugemalimabDrug: PegaspargaseDrug: GemcitabineDrug: 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.

Drug: PlaceboDrug: PegaspargaseDrug: GemcitabineDrug: Oxaliplatin

Interventions

SugemalimabBIOLOGICAL

IV infusion

Sugemalimab+PGemOx
PlaceboDRUG

IV infusion

Placebo+PGemOx
PegaspargaseDRUG

Intramuscular injection

Placebo+PGemOxSugemalimab+PGemOx
GemcitabineDRUG

IV infusion

Placebo+PGemOxSugemalimab+PGemOx
OxaliplatinDRUG

IV infusion

Placebo+PGemOxSugemalimab+PGemOx

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

sugemalimabpegaspargaseGemcitabineOxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Qinzhou Qi

    CStone Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Wenyun Zhang

CONTACT

+86 021-60333416cstoneRA@cstonepharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

February 5, 2026

Record last verified: 2026-02