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Tests treatment safety and results for Natural Killer/T-cell Lymphoma
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
ClinicalTrials.gov ID: NCT06966154
What this study is testing
What is tislezumab?
tislezumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for natural killer/t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntarily participate in the clinical study; fully understand and provide informed consent (via a signed Informed Consent Form, ICF); willing and...
- 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).
You likely can't join if
- History of malignancy within the past 5 years, with the exception of: Locally curable malignancies treated with curative intent (e.g., basal or...
- 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...
- 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).
See the full eligibility criteria
Who can 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.
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shangai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shangai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.