Actively Recruiting
A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of R/R NKTCL
Led by Fudan University · Updated on 2025-05-30
68
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label, multicenter Ib/II phase clinical trial investigates the safety, tolerability, and preliminary efficacy of tislezumab (anti-PD-1 monoclonal antibody), golidocitinib (JAK1/STAT3 signaling pathway inhibitor), and selinexor (selective inhibitor of nuclear export, XPO1 antagonist) in patients with relapsed/refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) progressing after ≥1 line of L-asparaginase-containing chemotherapy or chemoradiotherapy.
CONDITIONS
Official Title
A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of R/R NKTCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and provide informed consent
- Confirmed diagnosis of extranodal NK/T-cell lymphoma, nasal type
- Relapsed or refractory disease after asparaginase-based chemotherapy with or without radiotherapy
- For Phase II: prior anti-PD-1 antibody therapy and refractory status
- At least one measurable or evaluable lesion according to Lugano 2014 criteria
- Age 18 years or older at consent
- Life expectancy greater than 12 weeks
- ECOG performance status of 0 to 2
- Adequate organ and bone marrow function as defined by specific laboratory values
- Negative pregnancy test for women of childbearing potential within 7 days before enrollment
- Agreement to use effective contraception during the study and for 6 months after last dose
You will not qualify if you...
- History of malignancy within 5 years except certain locally curable cancers
- Allogeneic stem cell transplant within 5 years or autologous transplant within 3 months prior to first dose
- Prior use of JAK, STAT3, or XPO1 inhibitors
- Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants not discontinued before first dose
- Recent use of systemic glucocorticoids, immunosuppressants, cytotoxic chemotherapy, or anticancer therapy within specified time frames
- Major surgery within 6 weeks or radiotherapy within 90 days prior to enrollment
- Participation in other investigational drug trials within 30 days or recent vaccine administration except influenza vaccine
- Active infections such as tuberculosis, HIV, chronic hepatitis B or C, or other viral infections requiring treatment
- Uncontrolled cardiac conditions including heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Persistent drug-related toxicities above Grade 1 except alopecia
- Gastrointestinal conditions affecting drug absorption
- Pregnancy, lactation, or refusal to use contraception
- Psychiatric disorders or inability to consent
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dept of lymphoma and medical oncology, Shanghai Cancer Center
Shanghai, Shangai, China, 200032
Actively Recruiting
Research Team
R
Rong Tao, MD & PhD
CONTACT
C
Chuanxu Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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