Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Kil… (NCT06793956) | Clinical Trial Compass
RecruitingPhase 1
Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
China12 participantsStarted 2025-02-21
Plain-language summary
This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Pathologically confirmed extranodal NKTCL.
✓. Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.
✓. Age ≥ 18 years.
✓. Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen.
✓. ECOG performance status: 0-2.
✓. Estimated survival time ≥ 3 months.
✓. At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria.
✓. Adequate organ and bone marrow function.
Exclusion criteria
✕. Patients previously treated with PI3K inhibitors.
✕. Patients with hemophagocytic syndrome.
✕. Patients known to be allergic to any component of monoclonal antibodies.
✕. Patients with a history of other malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin).
✕. Patients with aggressive NK-cell leukemia or central nervous system involvement.
. Patients who have participated in other drug clinical trials within 4 weeks prior to the start of this study or have received anti-tumor treatment within 4 weeks before the study initiation.
✕. Patients with clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction) or patients who have undergone total gastrectomy.
✕. Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).