Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial

Phase 1

Terminated

• Conditions: Extranodal NK/T Cell Lymphoma, Nasal Type
• Interventions: Drug: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)

• Registration Number: NCT04602065
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Study Start: 2020-11-24
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Previously received anti-PD1/PD-L1 antibodies	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	IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)	Patients previously never received anti-PD1/PD-L1 antibodies.

Primary Outcome Measures

Name	Time	Method
ORR(evaluated by the independent review committee according to Lyric 2016 criteria.)	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).

Secondary Outcome Measures

Name	Time	Method
DCR	After the last subject completed follow-up visit of up to 24 weeks	To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
TTR2016 criteria.)	After the last subject completed follow-up visit of up to 24 weeks	To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
ORR	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) determined by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria
CR/PR	After the last subject completed follow-up visit of up to 24 weeks	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)
DOR	After the last subject completed follow-up visit of up to 24 weeks	To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
PFS	After the last subject completed follow-up visit of up to 24 weeks	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)
OS(evaluated 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	To evaluate the overall survival (OS) and OS at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)
adverse events	from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.	To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type)

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangdong, China