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

April 17, 2024 updated by: LIANG WANG, Beijing Tongren Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm, single-center Ib/II clinical trial that included an initial safety run-in phase with safety monitoring before the main enrollment (expansion phase).The aim of phase Ib is to evaluate the recommended phase 2 dose and dose-limiting toxicity (DLT), and the aim of phase II study is to evaluate, for the first time, the safety and efficacy of the treatment of Linperlisib combined with PD-1 blockade Camrelizumab and Pegaspargase in patients diagnosed with advanced or r/r ENKTL, respectively.

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Liang Wang
        • Contact:
        • Principal Investigator:
          • Liang Wang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histopathology and immunohistochemistry confirmed diagnosis of ENKTL according to WHO 2016 criteria.
  • refractory or relapsed after initial remission, or Ann-Arbor stage III-IV de novo patients
  • PET/CT or CT/MRI with at least one objectively evaluable lesion.
  • Expected to survive more than 3 months.
  • General status ECOG score 0-2 points.
  • The laboratory test within 1 week before enrollment meets the following conditions:

Blood routine: WBC≥3×10e9/L, PLT≥75×10e9/L, ANC≥1.5×10e9/L. sCR≤1.5 mg/dL,GFR≥50 ml/min. Liver function: ALT & AST≤3 times the upper limit of normal, TBIL ≤2 times the upper limit of normal.

Serum fibrinogen level≥1.0 g/L.

•Sign the informed consent form

Exclusion Criteria:

  • Patients with CNS involvement, or with other neoplasm;
  • Patients has received PI3K inhibitor treatment before enrollment
  • Poor performance status, ECOG≥2;
  • Patients in lactation or pregnancy；
  • Patients (male or female) have the possibility of childbirth but are unwilling or have not taken effective contraceptive measures；
  • Patients allergic to any of the study drugs；
  • Patients with active infection；
  • Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Patients with a history of interstitial pneumonia, non infectious pneumonia, or highly suspected interstitial pneumonia;
  • Patients with a history of neurological or psychiatric disorders, including epilepsy or dementia, in the past
  • According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Linperlisib
Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.
Other Names:
  • YY-20394
Drug: Camrelizumab
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.
Other Names:
  • Camrelizumab for Injection
Drug: Pegaspargase

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.

Other Names:
  • Pegaspargase injection
Drug: Dexamethasone
Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.
Other Names:
  • Dexamethasone oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The best objective response rate（ORR） over 6 treatment cycles
Time Frame: Within 6 treatment cycles (each cycle is 21 days)
Overall response rate means sum of complete response rate and partial response rate
Within 6 treatment cycles (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate（ORR）
Time Frame: At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)
Objective response rate means sum of complete response rate and partial response rate
At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)
Complete Response （CR）
Time Frame: At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)
CR was defined as complete remission evaluated using PET-CT scan or BM test
At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)
Progression Free Survival (PFS)
Time Frame: From date of enrollment until the date of progression or date of death from any cause, whichever came first, assesed up to 2 years.
Progression free survival was defined as the period from the start of treatment to the date of confirmed disease progression or death from any cause.
From date of enrollment until the date of progression or date of death from any cause, whichever came first, assesed up to 2 years.
Overall Survival (OS)
Time Frame: From date of enrollment until the date of documented death from any cause or follow up, whichever came first, assesed up to 2 years.
Overall survival is defined as the time from the date of treatment to the date of death.
From date of enrollment until the date of documented death from any cause or follow up, whichever came first, assesed up to 2 years.
Disease Control Rate（DCR）
Time Frame: Up to 2 years after enrollment.
Disease control rate discribes the percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease
Up to 2 years after enrollment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug safety
Time Frame: up to 2 years after enrollment
According to NCI CTCAE v5.0
up to 2 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Investigators

  • Principal Investigator: Liang Wang, M.D., Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREC2024-KY016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on T-lymphoblastic Lymphoma

Clinical Trials on Linperlisib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe