Extranodal Natural Killer/T Cell LymphomaPhase 1NCT06793956
Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
A Phase 1 study testing Sintilimab and Linperlisib Combination Treatment in people with Extranodal Natural Killer/T Cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extranodal Natural Killer/T Cell Lymphoma
- What is being tested?
- Sintilimab and Linperlisib Combination Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2025to 31 Jan 2030
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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
Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong, 51000
Qingqing Cai, 0086-20-87342823, caiqq@sysucc.org.cn
About this study
Official title: Open-Label, Phase Ib Study of Sintilimab and Linperlisib Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (NKTCL)
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).
- Being tested
- Sintilimab and Linperlisib Combination Treatment
- Keywords
- Sintilimab, Linperlisib, Extranodal Natural Killer/T Cell Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab and Linperlisib Combination TreatmentDrug
Sintilimab administered via intravenous infusion; Linperlisib administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab and Linperlisib Combination Treatment | Experimental | Not described Receives: Drug: Sintilimab and Linperlisib Combination Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-limiting toxicity
Measured: Cycle 1 (21 days)
RP2D
Phase II Recommended Dose
Measured: Cycle 1 (21 days)
Secondary outcomes (4)
Objective response rate (ORR)
To investigate the antitumor efficacy
Measured: Up to 24 weeks
AE and SAE
Number of participants with adverse events (AE) and severe adverse events (SAE)
Measured: Up to 24 weeks
2-year Progression-free survival(PFS)
To investigate the antitumor efficacy
Measured: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
2-year Overall survival(OS)
To investigate the antitumor efficacy
Measured: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start21 Feb 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal Natural Killer/T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793956
- Sponsor's protocol ID
- B2024-753
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Phase Ib Study of Sintilimab and Linperlisib Combination Treatment in Patients with Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma (NKTCL)
- ClinicalTrials.gov ID
- NCT06793956
- Acronym / sponsor ID
- B2024-753
- Keywords
- Sintilimab, Linperlisib, Extranodal Natural Killer/T Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 27 Jan 2025 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab and Linperlisib Combination Treatment | Experimental | Drug: Sintilimab and Linperlisib Combination Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Sintilimab and Linperlisib Combination TreatmentSintilimab administered via intravenous infusion; Linperlisib administered orally. | Drug | Sintilimab and Linperlisib Combination Treatment |
Primary outcome
DLT
Time frame: Cycle 1 (21 days)
Dose-limiting toxicity
RP2D
Time frame: Cycle 1 (21 days)
Phase II Recommended Dose
4 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 24 weeks
AE and SAE
Time frame: Up to 24 weeks
2-year Progression-free survival(PFS)
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
2-year Overall survival(OS)
Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of 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 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sintilimab and Linperlisib Combination Treatment in people with Extranodal Natural Killer/T Cell Lymphoma, run by Sun Yat-sen University 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 8 inclusion and 8 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 13 Mar 2025. 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 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.
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 Qingqing Cai, MD. PhD. (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Cycle 1 (21 days)). The study lists 2 primary outcomes in all. 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 13 Mar 2025.