Extranodal NK/T Cell Lymphoma, Nasal TypePhase 1/2NCT04602065
Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial
A Phase 1/2 study testing IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody) in people with Extranodal NK/T Cell Lymphoma, Nasal Type, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type). 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?
- IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2020to 28 Feb 2023
- Phase
- Phase 1/2
- 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 diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria;
- Refractory and relapsed ENKTL patients, being relapsed is defined as re-occurrence of the same lymphoma lesions at the primary site or new sites after complete response (CR); being refractory is defined as having any of the following conditions: evaluated as stable disease (SD) or progression disease (PD) after 2 cycles of treatment; not being able to achieve partial response (PR) after 4 cycles of treatment; not being able to achieve complete response (CR) after 6 cycles of treatment. Patients that did not achieve remission, or relapsed/progressed after autologous stem cell transplantation (ASCT) could also be enrolled.
- Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously).
- With measurable foci, defined as: lymph nodes with long diameters>15mm，extra-nodal foci>10mm on CT scan;
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1;
Who cannot join
- Invasive NK cell leukemia;
- Primary CNS lymphoma or CNS-involved lymphoma;
- Patients with hemophagocytic syndrome;
- Patients with lymphoma invading large pulmonary vessels;
- Patients primarily resistant to anti-PD1,PD-L1,PD-L2 antibodies (generally considered as those received anti- PD1,PD-L1,PD-L2 antibodies as monotherapy or in combination with chemotherapy, but did not achieve PR or CR in non-maintenance treatment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type), a Multicenter, Open-label Phase Ib/II Trial
The purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
- Being tested
- IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)
- Keywords
- ENKTL
- 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.
IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)Drug
IBI318, 300mg, Q2W, Intravenous influsion.
| Study group | Role | What they receive |
|---|---|---|
| Previously received anti-PD1/PD-L1 antibodies | Experimental | Patients previously received anti-PD1/PD-L1 antibodies, except for those were primarily refractory to them. Receives: Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody) |
| Patients previously never received anti-PD1/PD-L1 antibodies | Experimental | Patients previously never received anti-PD1/PD-L1 antibodies. Receives: Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(evaluated by the independent review committee according to Lyric 2016 criteria.)
To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
Measured: After the last subject completed follow-up visit of up to 24 weeks
Secondary outcomes (8)
ORR
To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) determined by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria
Measured: After the last subject completed follow-up visit of up to 24 weeks
CR/PR
To evaluate the complete response (CR) rate and partial response (PR) rate of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Measured: After the last subject completed follow-up visit of up to 24 weeks
DCR
To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Measured: After the last subject completed follow-up visit of up to 24 weeks
TTR2016 criteria.)
To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Measured: After the last subject completed follow-up visit of up to 24 weeks
DOR
To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Measured: After the last subject completed follow-up visit of up to 24 weeks
PFS
To evaluate the progression-free survival (PFS) and PFS rate at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Measured: After the last subject completed follow-up visit of up to 24 weeks
OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.)
To evaluate the overall survival (OS) and OS at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Measured: After the last subject completed follow-up visit of up to 24 weeks
adverse events
To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
Measured: from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start24 Nov 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
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 Innovent Biologics (Suzhou) 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602065
- Sponsor's protocol ID
- CIBI318B201
- Status last verified
- Mar 2023
- First submitted
- 30 Sep 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type), a Multicenter, Open-label Phase Ib/II Trial
- ClinicalTrials.gov ID
- NCT04602065
- Acronym / sponsor ID
- CIBI318B201
- Keywords
- ENKTL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 26 Oct 2020 (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 purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously received anti-PD1/PD-L1 antibodies | Experimental | Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)Patients previously received anti-PD1/PD-L1 antibodies, except for those were primarily refractory to them. |
| Patients previously never received anti-PD1/PD-L1 antibodies | Experimental | Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)Patients previously never received anti-PD1/PD-L1 antibodies. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria;
- Refractory and relapsed ENKTL patients, being relapsed is defined as re-occurrence of the same lymphoma lesions at the primary site or new sites after complete response (CR); being refractory is defined as having any of the following conditions: evaluated as stable disease (SD) or progression disease (PD) after 2 cycles of treatment; not being able to achieve partial response (PR) after 4 cycles of treatment; not being able to achieve complete response (CR) after 6 cycles of treatment. Patients that did not achieve remission, or relapsed/progressed after autologous stem cell transplantation (ASCT) could also be enrolled.
- Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously).
- With measurable foci, defined as: lymph nodes with long diameters>15mm，extra-nodal foci>10mm on CT scan;
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1;
Key exclusion criteria (5 listed)
- Invasive NK cell leukemia;
- Primary CNS lymphoma or CNS-involved lymphoma;
- Patients with hemophagocytic syndrome;
- Patients with lymphoma invading large pulmonary vessels;
- Patients primarily resistant to anti-PD1,PD-L1,PD-L2 antibodies (generally considered as those received anti- PD1,PD-L1,PD-L2 antibodies as monotherapy or in combination with chemotherapy, but did not achieve PR or CR in non-maintenance treatment).
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 |
|---|---|---|
| IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)IBI318, 300mg, Q2W, Intravenous influsion. | Drug | Patients previously never received anti-PD1/PD-L1 antibodies, Previously received anti-PD1/PD-L1 antibodies |
Primary outcome
ORR(evaluated by the independent review committee according to Lyric 2016 criteria.)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
8 secondary outcomes
ORR
Time frame: After the last subject completed follow-up visit of up to 24 weeks
CR/PR
Time frame: After the last subject completed follow-up visit of up to 24 weeks
DCR
Time frame: After the last subject completed follow-up visit of up to 24 weeks
TTR2016 criteria.)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
DOR
Time frame: After the last subject completed follow-up visit of up to 24 weeks
PFS
Time frame: After the last subject completed follow-up visit of up to 24 weeks
OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.)
Time frame: After the last subject completed follow-up visit of up to 24 weeks
adverse events
Time frame: from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.
Results and safety
The study was stopped early (reason given: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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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 1/2 study testing IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody) in people with Extranodal NK/T Cell Lymphoma, Nasal Type, run by Innovent Biologics (Suzhou) 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Mar 2023. 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?
The study was stopped early (reason given: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.). 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?
ORR(evaluated by the independent review committee according to Lyric 2016 criteria.) (time frame: After the last subject completed follow-up visit of up to 24 weeks). 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 15 Mar 2023.