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

November 7, 2023 updated by: CStone Pharmaceuticals

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugemalimab+PGemOx
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.
Drug: Gemcitabine
IV infusion
Drug: Oxaliplatin
IV infusion
Biological: Sugemalimab
IV infusion
Drug: Pegaspargase
Intramuscular injection
Placebo Comparator: Placebo+PGemOx
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: Placebo
IV infusion
Drug: Gemcitabine
IV infusion
Drug: Oxaliplatin
IV infusion
Drug: Pegaspargase
Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Approximately 39 months after First Patient In

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Approximately 39 months after First Patient In
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
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
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
Approximately 39 months after First Patient In

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CStone Pharmaceuticals

Investigators

  • Study Director: Qinzhou Qi, CStone Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS1001-306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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