Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypePhase 1/2NCT06376721
Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
A Phase 1/2 study testing Linperlisib, Camrelizumab and Pegaspargase in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type and T-lymphoblastic Lymphoma, run by Beijing Tongren Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, T-lymphoblastic Lymphoma
- What is being tested?
- Linperlisib, Camrelizumab and Pegaspargase
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2024to 31 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Liang Wang
Beijing, Beijing Municipality
Liang Wang, M.D., +8615001108693, wangliangtrhos@126.com
Liang Wang, M.D.
About this study
Official title: 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.
Read the 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.
- Being tested
- Linperlisib, Camrelizumab, Pegaspargase, Dexamethasone
- Keywords
- r/r ENKTL, Linperlisib, PD-1 blockade, Pegaspargase
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinperlisibDrug
Also called YY-20394
Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.
CamrelizumabDrug
Also called Camrelizumab for Injection
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.
PegaspargaseDrug
Also called Pegaspargase injection
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.
DexamethasoneDrug
Also called Dexamethasone oral
Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | 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) Receives: Drug: Linperlisib; Drug: Camrelizumab; Drug: Pegaspargase; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The best objective response rate（ORR） over 6 treatment cycles
Overall response rate means sum of complete response rate and partial response rate
Measured: Within 6 treatment cycles (each cycle is 21 days)
Secondary outcomes (5)
Objective Response Rate（ORR）
Objective response rate means sum of complete response rate and partial response rate
Measured: At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)
Complete Response （CR）
CR was defined as complete remission evaluated using PET-CT scan or BM test
Measured: At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)
Progression Free Survival (PFS)
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.
Measured: 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)
Overall survival is defined as the time from the date of treatment to the date of death.
Measured: 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）
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
Measured: Up to 2 years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start14 Apr 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment with linperlisib in combination with camrelizumab and pegaspargase for advanced or relapsed/refractory ENKTCL patients
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG WANG, Beijing Tongren Hospital
- Investigators
- Liang Wang, M.D., Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376721
- Sponsor's protocol ID
- TREC2024-KY016
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06376721
- Acronym / sponsor ID
- TREC2024-KY016
- Keywords
- r/r ENKTL, Linperlisib, PD-1 blockade, Pegaspargase
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment with linperlisib in combination with camrelizumab and pegaspargase for advanced or relapsed/refractory ENKTCL patients
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Linperlisib, Drug: Camrelizumab, Drug: Pegaspargase, Drug: DexamethasoneLinperlisib: 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinperlisibAlso: YY-20394Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD. | Drug | treatment arm |
| CamrelizumabAlso: Camrelizumab for InjectionCamrelizumab 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. | Drug | treatment arm |
| PegaspargaseAlso: Pegaspargase injectionPegaspargase: 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. | Drug | treatment arm |
| DexamethasoneAlso: Dexamethasone oralDexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee. | Drug | treatment arm |
Primary outcome
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
5 secondary outcomes
Objective Response Rate（ORR）
Time frame: 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)
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.
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.
Disease Control Rate（DCR）
Time frame: Up to 2 years after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang Wang, M.D. principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Linperlisib, Camrelizumab and Pegaspargase in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type and T-lymphoblastic Lymphoma, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Wang, M.D. (+861058268442, wangliangtrhos@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The best objective response rate（ORR） over 6 treatment cycles (time frame: Within 6 treatment cycles (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.