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

Sponsor
Beijing Tongren Hospital
Study ID
NCT06376721
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Linperlisib — DRUG
    Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.
  • Camrelizumab — DRUG
    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.
  • Pegaspargase — DRUG
    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.
  • Dexamethasone — DRUG
    Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.

Study Details

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.

Key Dates

Start date
Apr 14, 2024
Status verified
Apr 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment arm
    Linperlisib: Phase Ib：oral, 80 mg/d, QD; Phase II： oral, RP2D, QD. Camrelizumab for Injection: Phase Ib \& Phase II：intravenous drip, 200 mg/d, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) Pegaspargase: Phase Ib \& Phase II：intramuscular injection，2500 IU/m2, Q3W, administered on day 1 of each cycle (3 weeks in each cycle)

Primary Outcome Measure

The best objective response rate（ORR） over 6 treatment cycles [ Time Frame: Within 6 treatment cycles (each cycle is 21 days) ]

Central Contacts