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

NCT ID: NCT04602065

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2023-02-28

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).

Conditions

Extranodal NK/T Cell Lymphoma, Nasal Type

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Previously received anti-PD1/PD-L1 antibodies

Patients previously received anti-PD1/PD-L1 antibodies, except for those were primarily refractory to them.

Group Type: EXPERIMENTAL

IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)

Intervention Type: DRUG

IBI318, 300mg, Q2W, Intravenous influsion.

Patients previously never received anti-PD1/PD-L1 antibodies

Patients previously never received anti-PD1/PD-L1 antibodies.

Group Type: EXPERIMENTAL

IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)

Intervention Type: DRUG

IBI318, 300mg, Q2W, Intravenous influsion.

Interventions

IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)

IBI318, 300mg, Q2W, Intravenous influsion.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangdong, , China

Countries

China

Other Identifiers

CIBI318B201

Identifier Type: -

Identifier Source: org_study_id