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

Recruiting now · Phase 1/Phase 2

Conditions studied: Natural Killer/T-cell Lymphoma, Relapsed or Refractory Lymphoma Including ENKL

In brief

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.

Key facts

Study ID

NCT06966154

Run by

Fudan University

People needed

68

Starts

2025-05-26

Expected to finish

2028-05-30

Last updated by the study team

2025-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily participate in the clinical study; fully understand and provide informed consent (via a signed Informed Consent Form, ICF); willing and able to comply with all trial procedures.
• Histopathologically confirmed diagnosis of extranodal NK/T-cell lymphoma, nasal type (NKTCL) by the participating study center.
• Relapsed or refractory NKTCL after failure of asparaginase-based chemotherapy ± radiotherapy:
• Relapse: Disease recurrence >6 months after achieving complete response (CR) to prior therapy.
• Refractory: Failure to achieve CR or disease progression after adequate systemic therapy (≥4 cycles of a combination regimen).
• For Phase II: Patients must have received prior anti-PD-1 monoclonal antibody therapy and remain refractory.
• At least one measurable or evaluable lesion per Lugano 2014 criteria:
• Measurable lesion: CT/MRI: Longest diameter ≥1.5 cm (lymph nodes) or ≥1.0 cm (extranodal lesions).Post-radiation lesions require radiological evidence of progression.
• Evaluable lesion: FDG-PET: Lymph node/extranodal lesion with uptake > liver and imaging consistent with lymphoma.
• Age ≥18 years at the time of ICF signing.
• Life expectancy >12 weeks.
• ECOG performance status 0-2.
• Adequate organ and bone marrow function:
• Hematology (no transfusion/G-CSF support within 14 days): ANC ≥1.5×10⁹/L (≥0.5×10⁹/L if bone marrow involvement)；Platelets ≥100×10⁹/L (≥50×10⁹/L if bone marrow involvement)；Hemoglobin ≥8.0 g/dL.
• Liver function: Total bilirubin ≤1.5×ULN (≤3.0×ULN for Gilbert's syndrome or liver involvement).
• ALT/AST ≤2.5×ULN (≤5.0×ULN with liver involvement).
• Renal function: Serum creatinine ≤1.5×ULN OR creatinine clearance (Cockcroft-Gault) ≥50 mL/min.
• Coagulation: INR ≤1.5×ULN; PT/APTT ≤1.5×ULN (unless on anticoagulants within therapeutic range).
• Cardiac function: LVEF ≥50% by echocardiography (ECHO).
• Recovery from prior anticancer therapy toxicities to CTCAE v5.0 Grade ≤1 or baseline. Exceptions: Irreversible Grade 2 toxicities unlikely to worsen during the study (e.g., neuropathy, alopecia) per investigator's assessment.
• For women of childbearing potential (WOCBP): Negative serum pregnancy test within 7 days before enrollment. WOCBP and male participants with WOCBP partners must agree to use effective contraception from ICF signing until ≥6 months after the last study dose.

You may not qualify if…

• History of malignancy within the past 5 years, with the exception of: Locally curable malignancies treated with curative intent (e.g., basal or squamous cell skin cancer, thyroid carcinoma, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast).
• Any of the following prior treatments:
• History of allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 5 years prior to the first dose (patients with allo-HSCT >5 years before the first dose and no active graft-versus-host disease may enroll).
• Autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to the first dose.
• Prior use of JAK inhibitors, STAT3 inhibitors, or XPO1 inhibitors.
• Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants (or inability to discontinue within 1 week before the first dose).
• Systemic glucocorticoids or immunosuppressants within 14 days prior to enrollment (allowed: topical, ocular, intra-articular, intranasal, or inhaled glucocorticoids; short-term [≤7 days] prophylactic use for non-autoimmune conditions).
• Cytotoxic chemotherapy within 14 days prior to enrollment.
• Systemic anticancer therapy (including monoclonal antibodies or immunotherapy) within 4 weeks prior to the first dose.
• Major organ surgery within 6 weeks or radiotherapy within 90 days prior to enrollment.
• Radioimmunoconjugate therapy within 10 weeks prior to enrollment.
• Use of other investigational drugs requiring investigator's risk-benefit assessment.
• Participation in other clinical trials with investigational drugs within 30 days prior to enrollment.
• Vaccines (except influenza vaccines) within 28 days prior to enrollment.
• Active infections, including:
• Active or latent tuberculosis (positive tuberculin skin test [PPD] with induration ≥10 mm or radiologically confirmed active lesions).
• Known HIV infection or AIDS.
• Chronic active hepatitis B or C:
• HBV: Exclude if HBV DNA detectable (↑center-specific ULN). HCV: Exclude if HCV RNA detectable (↑center-specific ULN).
• Other active viral infections (e.g., herpes zoster, CMV) requiring treatment. Infections requiring intravenous antimicrobial therapy.
• Uncontrolled cardiac conditions, including:
• NYHA Class >II heart failure.
• Unstable angina.
• Myocardial infarction within 1 year.
• Clinically significant arrhythmias requiring intervention.

Where it is running

• Dept of lymphoma and medical oncology, Shanghai Cancer Center — Shanghai, Shangai, China (enrolling)

Full record on ClinicalTrials.gov

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