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

Extranodal NK/T-cell Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05700448
• Other study ID #: CS1001-306
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2024
• Est. completion date: November 2028

Study information

• Verified date: November 2023
• Source: CStone Pharmaceuticals
• Contact: Hua Hu
• Phone: +86 021-60333416
• Email: cstoneRA[@]cstonepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2028
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral

Intervention

Biological:
• Sugemalimab
IV infusion

Drug:
• Placebo
IV infusion
• Pegaspargase
Intramuscular injection
• Gemcitabine
IV infusion
• Oxaliplatin
IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CStone Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)		Approximately 39 months after First Patient In
Secondary	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
Secondary	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
Secondary	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