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Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma

Primary Purpose

Extranodal NK/T-cell Lymphoma

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sugemalimab
Placebo
Pegaspargase
Gemcitabine
Oxaliplatin
Sponsored by
CStone Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sugemalimab+PGemOx

    Placebo+PGemOx

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Overall survival (OS)
    Progression-free survival (PFS) evaluated by the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    Objective response rate (ORR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
    Duration of response (DoR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

    Full Information

    First Posted
    January 17, 2023
    Last Updated
    January 17, 2023
    Sponsor
    CStone Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05700448
    Brief Title
    Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    October 2026 (Anticipated)
    Study Completion Date
    October 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CStone Pharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Extranodal NK/T-cell Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sugemalimab+PGemOx
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo+PGemOx
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Sugemalimab
    Intervention Description
    IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Pegaspargase
    Intervention Description
    Intramuscular injection
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Intervention Description
    IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Oxaliplatin
    Intervention Description
    IV infusion
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Overall survival (OS)
    Time Frame
    Approximately 39 months after First Patient In
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hua Hu
    Phone
    +86 021-60333416
    Email
    cstoneRA@cstonepharma.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Qinzhou Qi
    Organizational Affiliation
    CStone Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma

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