RecruitingPhase 1Phase 2NCT06376721

Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

A Phase Ib/II Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

Sponsor

Beijing Tongren Hospital

Enrollment

43 participants

Start Date

Apr 14, 2024

Study Type

INTERVENTIONAL

Conditions

T-lymphoblastic Lymphoma Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Summary

The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — linperlisib, camrelizumab (an immunotherapy), and pegaspargase (a chemotherapy agent) — for people with a rare type of blood cancer called NK/T-cell lymphoma that has relapsed or not responded to initial treatment. **You may be eligible if...** - You have a confirmed diagnosis of extranodal NK/T-cell lymphoma (ENKTL) - Your cancer has relapsed after initial treatment, or it is stage III–IV and newly diagnosed - You have at least one measurable tumor on imaging - Your expected survival is more than 3 months - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - Your lymphoma has spread to the brain or central nervous system - You have another active cancer - Your blood counts or organ function are too low to safely receive treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinperlisib

Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.

DRUGCamrelizumab

Camrelizumab for Injection: 200 mg/d, intravenous drip for 30 min (not less than 20 min and not more than 60 min), administered on day 1 of each cycle, observed for 2 hours after infusion. Every 3 weeks is a dosing cycle. Cycle 2 and subsequent cycles of dosing may be administered up to 5 days before or after the day of the scheduled dosing; more than 3 days after the date of the scheduled dosing will be considered a delayed dosing.

DRUGPegaspargase

Pegaspargase: 2500 IU/m2, intramuscular injection, divided into three places, administered on the first day of each cycle, observed 2 hours after injection for the occurrence of anaphylactic reaction, if there is no anaphylactic reaction before giving other test drugs. Every 3 weeks as a dosing cycle. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.

DRUGDexamethasone

Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.

Locations(1)

Liang Wang

Beijing, Beijing Municipality, China

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NCT06376721

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