Natural Killer/T-cell LymphomaPhase 1/2NCT06966154
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
A Phase 1/2 study testing tislezumab, golidocitinib and Selinexor in people with Natural Killer/T-cell Lymphoma and Relapsed or Refractory Lymphoma Including ENKL, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Natural Killer/T-cell Lymphoma, Relapsed or Refractory Lymphoma Including ENKL
- What is being tested?
- tislezumab, golidocitinib and Selinexor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2025to 30 May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- Persistent drug-related toxicities >CTCAE Grade 1 (excluding alopecia) at baseline.
- Uncontrolled nausea/vomiting, chronic gastrointestinal diseases, dysphagia, or prior bowel resection affecting drug absorption.
- Pregnancy, lactation, or refusal to use contraception by participants of reproductive potential.
- Psychiatric disorders or inability to provide informed consent.
- Other conditions deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dept of lymphoma and medical oncology, Shanghai Cancer Center
Shanghai, Shangai, 200032
Chaunxu Liu, MD, 008621-64175590 ext. 660103, liuchaunxu@shca.or.cn
About this study
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 Relapsed/Refractory Natural Killer/T-Cell Lymphoma (NKTCL)
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.
Read the detailed description
This phase Ib/II open-label, multicenter clinical trial addresses the critical unmet need in relapsed/refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL), an aggressive Epstein-Barr virus (EBV)-associated non-Hodgkin lymphoma subtype characterized by extranodal predominance, angiocentric growth patterns, and geographic prevalence in Asian and Latin American populations. Despite incorporation of L-asparaginase-based regimens into first-line therapy, approximately 30-40% of patients experience primary refractory disease or relapse, with median overall survival (OS) of <6 months in PD-1 inhibitor-resistant cohorts and limited sustained responses to salvage therapies, highlighting the imperative for novel mechanism-driven combinations. The investigational triplet regimen-comprising tislelizumab (anti-PD-1 monoclonal antibody), golidocitinib (JAK1/STAT3 inhibitor), and selinexor (XPO1 antagonist)-was rationally designed to exploit synergistic mechanisms targeting ENKTL pathogenesis: PD-1 blockade reverses T-cell exhaustion, JAK/STAT3 inhibition disrupts constitutive oncogenic signaling (e.g., STAT3 Y705 phosphorylation), and XPO1 antagonism promotes nuclear retention of tumor suppressors (p53, IkBα) while destabilizing EBV latency proteins. Part 1 (Phase Ib) employs dose escalation across combinatorial cohorts to establish the recommended Phase II dose (RP2D), prioritizing safety and tolerability through rigorous assessment of dose-limiting toxicities (DLTs), while Part 2 (Phase II) evaluates preliminary efficacy in a dedicated anti-PD-1-refractory population, focusing on objective response rate (ORR) by Lugano 2014 criteria as the primary endpoint. The trial specifically targets patients with histologically confirmed ENKTL per WHO classification and radiographically confirmed progression post-L-asparaginase-containing therapy and failed to prior anti-PD-1/PD-L1 therapy, excluding those with prior exposure to JAK or XPO1 inhibitors to isolate the novel therapeutic effect. By integrating PD-1 pathway modulation with simultaneous disruption of STAT3-driven survival signals and viral oncoprotein dependencies, this combination strategy aims to discover the potential therapeutic paradigms for R/R ENKTL, particularly in populations failing contemporary immunochemotherapy approaches.
- Being tested
- tislezumab, golidocitinib, Selinexor
- Keywords
- natural killer/T-cell lymphoma, Immune checkpointor inhibitor, tislelizumab, golidocitinib, selinexor
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tislezumabDrug
Tislelizumab will be administered intravenously at a fixed dose of 200 mg every 3 weeks (Q3W).
golidocitinibDrug
Golidocitinib: Dose-escalating oral regimens:
Dose level A: 150 mg every other day (QOD). Dose level B: 150 mg once daily (QD).
SelinexorDrug
Selinexor: Dose-escalating oral regimens: Dose A: 40 mg once weekly (QW) . Dose B: 60 mg QW for 2 consecutive weeks, followed by 1 week off.
| Study group | Role | What they receive |
|---|---|---|
| tislezumab plus golidocitinib and selinexor | Experimental | Patients will receive Tislelizumab: Fixed intravenous dose of 200 mg every 3 weeks (Q3W).
Golidocitinib: Dose-escalating oral regimens:
Dose level A: 150 mg every other day (QOD). Dose level B: 150 mg once daily (QD).
Selinexor: Dose-escalating oral regimens:
Dose A: 40 mg once weekly (QW) . Dose B: 60 mg QW for 2 consecutive weeks, followed by 1 week off. Safety monitoring will be performed throughout each 3-week cycle, with dose escalation contingent on safety/tolerability assessments. Receives: Drug: tislezumab; Drug: golidocitinib; Drug: Selinexor |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D of golidocitinib in combination with selinexor
Recommended Phase II Dose of golidocitinib in combination with selinexor
Measured: 4 weeks after the initiation of combination treatment
Satety profile
Safety profile, including: Incidence, severity, and drug-relatedness of adverse events (AEs) and serious adverse events (SAEs) per NCI CTCAE ver 5.0
Measured: 6 months after the last lose of combination treatment
Overall response rate
Phase II (Dose-Expansion Phase) part 12-week objective response rate (ORR) assessed per Lugano 2014 criteria for lymphoma response evaluation.
Measured: 12-weeks after the initiation of combination treatment
Secondary outcomes (5)
Complete Response Rate
Phase II (Dose-Expansion Phase) part 12-week complete response rate (CRR) assessed per Lugano 2014 criteria for lymphoma response evaluation.
Measured: 12-weeks after the initiation of combination treatment
Duration of Response
Duration of Response (DoR) per Lugano 2014 response criteria
Measured: 12 months after the last patient enrolled
Progression-Free Survival (PFS)
The length of time from the start of treatment until disease progression or death from any cause, whichever occurs first.
Measured: 12 months after the last patient enrolled
Overall survival(OS)
The length of time from the start of treatment until death from any cause.
Measured: 12 months after the last patient enrolled
Treatment-Emergent Adverse Events（TEAE）
The incidence of TEAEs (Treatment-Emergent Adverse Events), AEs/SAEs/immune-related adverse events (irAEs), their association with the investigational drug, and their severity as assessed according to CTCAE v5.0.
Measured: 6 months after the last patient quit the trial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start26 May 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Natural Killer/T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase Ib (Safety Run-In Section) Guided by the Bayesian Optimal Interval (BOIN) design, the study explores the combined dosing of golidocitinib, selinexor, and tislelizumab across 2 dose levels and 4 dosing cohorts . Patients are sequentially enrolled in chronological order and assigned to one of the following combination regimens: Golidocitinib: 2 dose groups. Selinexor: 2 dose groups.Randomization is implemented within each dose level. The first treatment cycle (28-day cycle) is designated as the dose-limiting toxicity (DLT) observation period. Dose Escalation Rules: If both cohorts at Dose Level 1 (golidocitinib + selinexor combinations) demonstrate acceptable tolerability per the SRC, golidocitinib is escalated to the higher dose in Dose Level 2. If either cohort at Dose Level 1 is deemed intolerable by the SRC, de-escalation to Dose Level 0 (baseline dose) is mandated. Following completion of all 4 cohorts in Phase Ib, the recommended dose (RP2D) will be determined.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966154
- Sponsor's protocol ID
- SHCA-NKT-202501
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kwong YL, Chan TSY, Tan D, Kim SJ, Poon LM, Mow B, Khong PL, Loong F, Au-Yeung R, Iqbal J, Phipps C, Tse E. PD1 blockade with pembrolizumab is highly effective in relapsed or refractory NK/T-cell lymphoma failing l-asparaginase. Blood. 2017 Apr 27;129(17):2437-2442. doi: 10.1182/blood-2016-12-756841. Epub 2017 Feb 10.
PubMed 28188133Tao R, Liu C, Zhang W, Zhu Y, Ma Y, Hao S. Selinexor With Anti-PD-1 Antibody as a Potentially Effective Regimen for Patients With Natural Killer/T-Cell Lymphoma Failing Prior L-Asparaginase and PD-1 Blockade. Oncologist. 2024 Jan 5;29(1):e90-e96. doi: 10.1093/oncolo/oyad241.
PubMed 37616529Mathew D, Marmarelis ME, Foley C, Bauml JM, Ye D, Ghinnagow R, Ngiow SF, Klapholz M, Jun S, Zhang Z, Zorc R, Davis CW, Diehn M, Giles JR, Huang AC, Hwang WT, Zhang NR, Schoenfeld AJ, Carpenter EL, Langer CJ, Wherry EJ, Minn AJ. Combined JAK inhibition and PD-1 immunotherapy for non-small cell lung cancer patients. Science. 2024 Jun 21;384(6702):eadf1329. doi: 10.1126/science.adf1329. Epub 2024 Jun 21.
PubMed 38900877Song Y, Malpica L, Cai Q, Zhao W, Zhou K, Wu J, Zhang H, Mehta-Shah N, Ding K, Liu Y, Li Z, Zhang L, Zheng M, Jin J, Yang H, Shuang Y, Yoon DH, Gao S, Li W, Zhai Z, Zou L, Xi Y, Koh Y, Li F, Prince M, Zhou H, Lin L, Liu H, Allen P, Roncolato F, Yang Z, Kim WS, Zhu J. Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study. Lancet Oncol. 2024 Jan;25(1):117-125. doi: 10.1016/S1470-2045(23)00589-2. Epub 2023 Dec 9.
PubMed 38092009Tao R, Fan L, Song Y, Hu Y, Zhang W, Wang Y, Xu W, Li J. Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4). Signal Transduct Target Ther. 2021 Oct 27;6(1):365. doi: 10.1038/s41392-021-00768-0.
PubMed 34702811
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Relapsed/Refractory Natural Killer/T-Cell Lymphoma (NKTCL)
- ClinicalTrials.gov ID
- NCT06966154
- Acronym / sponsor ID
- SHCA-NKT-202501
- Keywords
- natural killer/T-cell lymphoma, Immune checkpointor inhibitor, tislelizumab, golidocitinib, selinexor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phase Ib/II open-label, multicenter clinical trial addresses the critical unmet need in relapsed/refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL), an aggressive Epstein-Barr virus (EBV)-associated non-Hodgkin lymphoma subtype characterized by extranodal predominance, angiocentric growth patterns, and geographic prevalence in Asian and Latin American populations. Despite incorporation of L-asparaginase-based regimens into first-line therapy, approximately 30-40% of patients experience primary refractory disease or relapse, with median overall survival (OS) of <6 months in PD-1 inhibitor-resistant cohorts and limited sustained responses to salvage therapies, highlighting the imperative for novel mechanism-driven combinations. The investigational triplet regimen-comprising tislelizumab (anti-PD-1 monoclonal antibody), golidocitinib (JAK1/STAT3 inhibitor), and selinexor (XPO1 antagonist)-was rationally designed to exploit synergistic mechanisms targeting ENKTL pathogenesis: PD-1 blockade reverses T-cell exhaustion, JAK/STAT3 inhibition disrupts constitutive oncogenic signaling (e.g., STAT3 Y705 phosphorylation), and XPO1 antagonism promotes nuclear retention of tumor suppressors (p53, IkBα) while destabilizing EBV latency proteins. Part 1 (Phase Ib) employs dose escalation across combinatorial cohorts to establish the recommended Phase II dose (RP2D), prioritizing safety and tolerability through rigorous assessment of dose-limiting toxicities (DLTs), while Part 2 (Phase II) evaluates preliminary efficacy in a dedicated anti-PD-1-refractory population, focusing on objective response rate (ORR) by Lugano 2014 criteria as the primary endpoint. The trial specifically targets patients with histologically confirmed ENKTL per WHO classification and radiographically confirmed progression post-L-asparaginase-containing therapy and failed to prior anti-PD-1/PD-L1 therapy, excluding those with prior exposure to JAK or XPO1 inhibitors to isolate the novel therapeutic effect. By integrating PD-1 pathway modulation with simultaneous disruption of STAT3-driven survival signals and viral oncoprotein dependencies, this combination strategy aims to discover the potential therapeutic paradigms for R/R ENKTL, particularly in populations failing contemporary immunochemotherapy approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase Ib (Safety Run-In Section) Guided by the Bayesian Optimal Interval (BOIN) design, the study explores the combined dosing of golidocitinib, selinexor, and tislelizumab across 2 dose levels and 4 dosing cohorts . Patients are sequentially enrolled in chronological order and assigned to one of the following combination regimens: Golidocitinib: 2 dose groups. Selinexor: 2 dose groups.Randomization is implemented within each dose level. The first treatment cycle (28-day cycle) is designated as the dose-limiting toxicity (DLT) observation period. Dose Escalation Rules: If both cohorts at Dose Level 1 (golidocitinib + selinexor combinations) demonstrate acceptable tolerability per the SRC, golidocitinib is escalated to the higher dose in Dose Level 2. If either cohort at Dose Level 1 is deemed intolerable by the SRC, de-escalation to Dose Level 0 (baseline dose) is mandated. Following completion of all 4 cohorts in Phase Ib, the recommended dose (RP2D) will be determined.
| Arm | Type | Receives |
|---|---|---|
| tislezumab plus golidocitinib and selinexor | Experimental | Drug: tislezumab, Drug: golidocitinib, Drug: SelinexorPatients will receive Tislelizumab: Fixed intravenous dose of 200 mg every 3 weeks (Q3W). Golidocitinib: Dose-escalating oral regimens: Dose level A: 150 mg every other day (QOD). Dose level B: 150 mg once daily (QD). Selinexor: Dose-escalating oral regimens: Dose A: 40 mg once weekly (QW) . Dose B: 60 mg QW for 2 consecutive weeks, followed by 1 week off. Safety monitoring will be performed throughout each 3-week cycle, with dose escalation contingent on safety/tolerability assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- At least one measurable or evaluable lesion per Lugano 2014 criteria:
- Age ≥18 years at the time of ICF signing.
Key exclusion criteria (30 listed)
- 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:
- Active infections, including:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tislezumabTislelizumab will be administered intravenously at a fixed dose of 200 mg every 3 weeks (Q3W). | Drug | tislezumab plus golidocitinib and selinexor |
| golidocitinibGolidocitinib: Dose-escalating oral regimens: Dose level A: 150 mg every other day (QOD). Dose level B: 150 mg once daily (QD). | Drug | tislezumab plus golidocitinib and selinexor |
| SelinexorSelinexor: Dose-escalating oral regimens: Dose A: 40 mg once weekly (QW) . Dose B: 60 mg QW for 2 consecutive weeks, followed by 1 week off. | Drug | tislezumab plus golidocitinib and selinexor |
Primary outcome
RP2D of golidocitinib in combination with selinexor
Time frame: 4 weeks after the initiation of combination treatment
Recommended Phase II Dose of golidocitinib in combination with selinexor
Satety profile
Time frame: 6 months after the last lose of combination treatment
Safety profile, including: Incidence, severity, and drug-relatedness of adverse events (AEs) and serious adverse events (SAEs) per NCI CTCAE ver 5.0
Overall response rate
Time frame: 12-weeks after the initiation of combination treatment
Phase II (Dose-Expansion Phase) part 12-week objective response rate (ORR) assessed per Lugano 2014 criteria for lymphoma response evaluation.
5 secondary outcomes
Complete Response Rate
Time frame: 12-weeks after the initiation of combination treatment
Duration of Response
Time frame: 12 months after the last patient enrolled
Progression-Free Survival (PFS)
Time frame: 12 months after the last patient enrolled
Overall survival(OS)
Time frame: 12 months after the last patient enrolled
Treatment-Emergent Adverse Events（TEAE）
Time frame: 6 months after the last patient quit the trial treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Results publication: PubMed 28188133Kwong YL, Chan TSY, Tan D, Kim SJ, Poon LM, Mow B, Khong PL, Loong F, Au-Yeung R, Iqbal J, Phipps C, Tse E. PD1 blockade with pembrolizumab is highly effective in relapsed or refractory NK/T-cell lymphoma failing l-asparaginase. Blood. 2017 Apr 27;129(17):2437-2442. doi: 10.1182/blood-2016-12-756841. Epub 2017 Feb 10.
- Results publication: PubMed 37616529Tao R, Liu C, Zhang W, Zhu Y, Ma Y, Hao S. Selinexor With Anti-PD-1 Antibody as a Potentially Effective Regimen for Patients With Natural Killer/T-Cell Lymphoma Failing Prior L-Asparaginase and PD-1 Blockade. Oncologist. 2024 Jan 5;29(1):e90-e96. doi: 10.1093/oncolo/oyad241.
- Results publication: PubMed 38900877Mathew D, Marmarelis ME, Foley C, Bauml JM, Ye D, Ghinnagow R, Ngiow SF, Klapholz M, Jun S, Zhang Z, Zorc R, Davis CW, Diehn M, Giles JR, Huang AC, Hwang WT, Zhang NR, Schoenfeld AJ, Carpenter EL, Langer CJ, Wherry EJ, Minn AJ. Combined JAK inhibition and PD-1 immunotherapy for non-small cell lung cancer patients. Science. 2024 Jun 21;384(6702):eadf1329. doi: 10.1126/science.adf1329. Epub 2024 Jun 21.
- Results publication: PubMed 38092009Song Y, Malpica L, Cai Q, Zhao W, Zhou K, Wu J, Zhang H, Mehta-Shah N, Ding K, Liu Y, Li Z, Zhang L, Zheng M, Jin J, Yang H, Shuang Y, Yoon DH, Gao S, Li W, Zhai Z, Zou L, Xi Y, Koh Y, Li F, Prince M, Zhou H, Lin L, Liu H, Allen P, Roncolato F, Yang Z, Kim WS, Zhu J. Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study. Lancet Oncol. 2024 Jan;25(1):117-125. doi: 10.1016/S1470-2045(23)00589-2. Epub 2023 Dec 9.
- Results publication: PubMed 34702811Tao R, Fan L, Song Y, Hu Y, Zhang W, Wang Y, Xu W, Li J. Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4). Signal Transduct Target Ther. 2021 Oct 27;6(1):365. doi: 10.1038/s41392-021-00768-0.
- Individual participant dataSharing planned: Undecided
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BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
Active, not recruitingPhase 1/2
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Relapsed or Refractory T-cell Lymphomas
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tislezumab, golidocitinib and Selinexor in people with Natural Killer/T-cell Lymphoma and Relapsed or Refractory Lymphoma Including ENKL, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Tao, MD & PhD (008621-64175590 ext. 660103, hkutao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D of golidocitinib in combination with selinexor (time frame: 4 weeks after the initiation of combination treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06966154, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.