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New treatment option for Extranodal NK/T-cell Lymphoma
Official title Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma
ClinicalTrials.gov ID: NCT07502768
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for extranodal nk/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 is a multicenter, open-label, phase Ib/II study evaluating tislelizumab in combination with zeprumetostat (SHR2554) in patients with relapsed or refractory NK/T-cell lymphoma after at least one prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy. In phase Ib, two fixed dose levels of zeprumetostat in combination with tislelizumab will be evaluated to determine the recommended phase II dose (RP2D).
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
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
- Age 18 years or older.
- Pathologically confirmed NK/T-cell lymphoma.
- Relapsed or refractory disease after at least 1 prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy.
- At least 1 measurable or evaluable lesion according to Lugano 2014 criteria.
- ECOG performance status 0 to 2.
You likely can't join if
- Prior treatment with any EZH1/2 or EZH2 inhibitor.
- Allogeneic hematopoietic stem cell transplantation within 5 years before study treatment.
- Autologous hematopoietic stem cell transplantation within 3 months before study treatment.
- Requirement for high-dose systemic corticosteroids or other immunosuppressive therapy within 14 days before study treatment, except permitted...
- Cytotoxic chemotherapy not discontinued within 14 days before study treatment.
- Systemic anti-cancer therapy or investigational therapy within 4 weeks before study treatment.
See the full eligibility criteria
- Age 18 years or older.
- Pathologically confirmed NK/T-cell lymphoma.
- Relapsed or refractory disease after at least 1 prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy.
- At least 1 measurable or evaluable lesion according to Lugano 2014 criteria.
- ECOG performance status 0 to 2.
- Life expectancy greater than 12 weeks.
- Adequate hematologic, hepatic, renal, coagulation, and cardiac function.
- Recovery from prior anti-cancer treatment-related toxicities to CTCAE grade 1 or baseline, except for specified stable irreversible toxicities allowed by the investigator.
- Negative pregnancy test for women of childbearing potential.
- Willingness to use effective contraception.
- Written informed consent.
- Prior treatment with any EZH1/2 or EZH2 inhibitor.
- Allogeneic hematopoietic stem cell transplantation within 5 years before study treatment.
- Autologous hematopoietic stem cell transplantation within 3 months before study treatment.
- Requirement for high-dose systemic corticosteroids or other immunosuppressive therapy within 14 days before study treatment, except permitted local/inhaled or short-course use.
- Cytotoxic chemotherapy not discontinued within 14 days before study treatment.
- Systemic anti-cancer therapy or investigational therapy within 4 weeks before study treatment.
- Major surgery within 4 weeks or radiotherapy within 90 days before study treatment.
- Active infection, including active/latent tuberculosis, HIV infection, active hepatitis B or C with detectable viral nucleic acid, or other clinically significant active viral infection.
- Uncontrolled cardiovascular disease.
- Persistent unresolved toxicities greater than CTCAE grade 1 from prior therapy, except alopecia.
- Gastrointestinal disorders or prior intestinal surgery that may impair oral drug absorption.
- Pregnancy or breastfeeding.
- Psychiatric illness or inability to provide informed consent.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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, Shanghai Municipality, 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.