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Trial Title:
Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma
NCT ID:
NCT05700448
Condition:
Extranodal NK/T-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Extranodal NK-T-Cell
Gemcitabine
Oxaliplatin
Pegaspargase
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
Sugemalimab
Description:
IV infusion
Arm group label:
Sugemalimab+PGemOx
Intervention type:
Drug
Intervention name:
Placebo
Description:
IV infusion
Arm group label:
Placebo+PGemOx
Intervention type:
Drug
Intervention name:
Pegaspargase
Description:
Intramuscular injection
Arm group label:
Placebo+PGemOx
Arm group label:
Sugemalimab+PGemOx
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
IV infusion
Arm group label:
Placebo+PGemOx
Arm group label:
Sugemalimab+PGemOx
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
IV infusion
Arm group label:
Placebo+PGemOx
Arm group label:
Sugemalimab+PGemOx
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
November 2024
Completion date:
November 2028
Lead sponsor:
Agency:
CStone Pharmaceuticals
Agency class:
Industry
Source:
CStone Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05700448
