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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04602065
Other study ID # CIBI318B201
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date November 24, 2020
Est. completion date February 28, 2023

Study information

Verified date March 2023
Source Innovent Biologics (Suzhou) Co. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Histologically diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria; 2. 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. 3. Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously). 4. With measurable foci, defined as: lymph nodes with long diameters>15mm,extra-nodal foci>10mm on CT scan; 5. ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1; Exclusion Criteria: 1. Invasive NK cell leukemia; 2. Primary CNS lymphoma or CNS-involved lymphoma; 3. Patients with hemophagocytic syndrome; 4. Patients with lymphoma invading large pulmonary vessels; 5. 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)
IBI318, 300mg, Q2W, Intravenous influsion.

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). After the last subject completed follow-up visit of up to 24 weeks
Secondary 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 After the last subject completed follow-up visit of up to 24 weeks
Secondary 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) After the last subject completed follow-up visit of up to 24 weeks
Secondary DCR To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) After the last subject completed follow-up visit of up to 24 weeks
Secondary TTR2016 criteria.) To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) After the last subject completed follow-up visit of up to 24 weeks
Secondary DOR To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) After the last subject completed follow-up visit of up to 24 weeks
Secondary 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) After the last subject completed follow-up visit of up to 24 weeks
Secondary 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) After the last subject completed follow-up visit of up to 24 weeks
Secondary adverse events To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.
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