Sintilimab and Linperlisib Combination Treatment in Relapsed or Refractory Extranodal Natural Killer/T Cell Lymphoma
Recruiting
Phase 1Interventional Study
Extranodal Natural Killer/T Cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Sun Yat-sen University · Other
Who this trial is looking for
This trial is looking for adults with a type of cancer called extranodal natural killer/T-cell lymphoma that hasn't responded to previous treatment. Participants will receive a combination of two drugs, sintilimab and linperlisib, to see how well they work together.
Are You a Good Fit for This Trial?
Rules you outInterstitial lung disease
You may be able to join if
I am at least 18 years old.
I have been diagnosed with extranodal natural killer/T-cell lymphoma.
I have had NKTCL that didn't respond to at least one past treatment.
I understand the study and agree to participate.
I have a measurable tumor according to specific criteria.
I have enough functioning organs and bone marrow.
I am expected to live for at least 3 months.
You may not be able to join if
I have been treated with PI3K inhibitors in the past.
I have a history of hemophagocytic syndrome.
I am allergic to any part of monoclonal antibodies.
I have had another type of cancer in the last 5 years.
I have aggressive NK-cell leukemia or cancer in my brain.
I took part in another drug trial within the last 4 weeks.
I have taken anti-tumor treatment in the last 4 weeks.
I have significant gastrointestinal issues that affect drug absorption.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Key Inclusion Criteria:
1. Pathologically confirmed extranodal NKTCL.
2. Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.
3. Age ≥ 18 years.
4. Relapsed or refractory NKTCL after failure of at least one line of asparaginas…
Key Inclusion Criteria:
1. Pathologically confirmed extranodal NKTCL.
2. Voluntary participation in the clinical study; fully understand the study, and have signed the written informed consent form.
3. Age ≥ 18 years.
4. Relapsed or refractory NKTCL after failure of at least one line of asparaginase-based chemotherapy or chemoradiotherapy regimen.
5. ECOG performance status: 0-2.
6. Estimated survival time ≥ 3 months.
7. At least one measurable lesion according to the Lugano 2014 lymphoma evaluation criteria.
8. Adequate organ and bone marrow function.
Key Exclusion Criteria:
1. Patients previously treated with PI3K inhibitors.
2. Patients with hemophagocytic syndrome.
3. Patients known to be allergic to any component of monoclonal antibodies.
4. Patients with a history of other malignancies within the past 5 years or concurrent malignancies (excluding basal cell carcinoma of the skin).
5. Patients with aggressive NK-cell leukemia or central nervous system involvement.
6. 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.
7. 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.
8. Patients with a history of interstitial lung disease (except for asymptomatic interstitial lung disease caused by radiotherapy).
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.