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

Extranodal NK/T Cell Lymphoma, Nasal Type Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04602065
• Other study ID #: CIBI318B201
• Status: Terminated
• Phase: Phase 1/Phase 2
• 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
• 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).

Related Conditions & MeSH terms

• Extranodal NK/T Cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral

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.