Extranodal NK/T-cell Lymphoma, Nasal TypePhase 2NCT03363555
SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
A Phase 2 study testing SHR-1210 in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 in subjects with relapsed or refractory extranodal NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma, Nasal Type
- What is being tested?
- SHR-1210
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2018to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed extranodal NK/T cell lymphoma;
- Relapsed or refrsctory cHL and received L-asparaginase based chemotherapy.
- Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
- Need to provide ≥5 tumor tissue sections for detection.
- ECOG performance status of 0 or 1;
- Life expectancy ≥ 12 weeks.;
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- Adequate laboratory parameters during the screening period as evidenced by the following:
- Absolute neutrophil count ≥ 1.0× 109/L ;
- Platelets ≥ 75 × 109/L;
- Hemoglobin ≥ 8.0 g/dL;
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN
- Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min;
- Coagulation function index：INR ≤1.5×ULN，APTT≤1.5×ULN
- Women of childbearing potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 60 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation; Male subjects with WOCBP partner should receive Surgical sterilization orconsent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
- Able to understand and sign an informed consent form (ICF).
Who cannot join
- invasive NK cell leukemia or precursor NK cell tumor
- Known central nervous system lymphoma
- Haemophilus cell syndrome at diagnosis
- Large lung vessels were involved
- History and complication
- Recieved anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months.
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- Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
- Participating in other clinical studies or less than 4 weeks before the end of a clinical trial;
- Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted.
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids > 10mg.
- Known and suspicion of interstitial pneumonia
- Other active malignancies that required treating.
- Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks. Previous anti-tumor therapy related adverse reactions (except trichomadesis) did not recover to CTCAE ≤1.
- Prior allo-HSCT.
- ASCT within 90 days.
- Impact of major surgery or severe trauma had been eliminated for less than 14 days.
- Active pulmonary tuberculosis.
- Severe acute or chronic infection requiring systemic therapy.
- Suffering from heart failure (New York Heart Association standard III or IV) and given appropriate medical treatment.Uncontrolled coronary artery disease and arrhythmia. History of myocardial infarction within 6 months.
- laboratory test
- known HIV positive or known AIDS.
- Untreated active hepatitis; Hepatitis B and hepatitis C infection in common.
- Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
This is an open-label, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 in subjects with relapsed or refractory extranodal NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
Read the detailed description
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory extranodal NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years，safety and immunogenicity of SHR-1210 in relapsed or refractory extranodal NK/T cell lymphoma.The relationship of PD-L1 expression in tumor tissue and EBV-DNA copies in blood to SHR-1210 efficacy in these patients would also be explored.
- Being tested
- SHR-1210
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Drug
A humanized monoclonal immunoglobulin.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1210 | Experimental | SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Receives: Drug: SHR-1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
rate of subjects achieved complete response plus partial response in all evaluable subjects
Measured: from first patient first visit to 6 month after last patient first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start29 May 2018
- Primary completion30 Jun 2019
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell Lymphoma, Nasal TypeStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363555
- Sponsor's protocol ID
- SHR-1210-II-205
- Status last verified
- Jun 2020
- First submitted
- 29 Nov 2017
- Last updated
- 18 Jun 2020
- Results posted
- 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 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03363555
- Acronym / sponsor ID
- SHR-1210-II-205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- Jun 2021 (estimated)
- First posted
- 6 Dec 2017 (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, multi-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 in subjects with relapsed or refractory extranodal NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
Detailed description
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory extranodal NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years，safety and immunogenicity of SHR-1210 in relapsed or refractory extranodal NK/T cell lymphoma.The relationship of PD-L1 expression in tumor tissue and EBV-DNA copies in blood to SHR-1210 efficacy in these patients would also be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1210 | Experimental | Drug: SHR-1210SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed extranodal NK/T cell lymphoma;
- Relapsed or refrsctory cHL and received L-asparaginase based chemotherapy.
- Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
- Need to provide ≥5 tumor tissue sections for detection.
- ECOG performance status of 0 or 1;
Key exclusion criteria (23 listed)
- invasive NK cell leukemia or precursor NK cell tumor
- Known central nervous system lymphoma
- Haemophilus cell syndrome at diagnosis
- Large lung vessels were involved
- History and complication
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 |
|---|---|---|
| SHR-1210A humanized monoclonal immunoglobulin. | Drug | SHR-1210 |
Primary outcome
objective response rate
Time frame: from first patient first visit to 6 month after last patient first visit
rate of subjects achieved complete response plus partial response in all evaluable subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1210 in people with Extranodal NK/T-cell Lymphoma, Nasal Type, run by Jiangsu HengRui Medicine Co., Ltd. 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 15 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 18 Jun 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: from first patient first visit to 6 month after last patient first visit). 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 18 Jun 2020.