A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combina
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/
| Condition(s) | Natural Killer/T-cell Lymphoma, Relapsed or Refractory Lymphoma Including ENKL |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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 measurabl |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fudan University |
| Locations | Shanghai, Shangai, China |
| Start date | 2025-05-26 |
| NCT ID | NCT06966154 |
| Official listing | https://clinicaltrials.gov/study/NCT06966154 |