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

Innovent Biologics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Extranodal NK/T Cell Lymphoma, Nasal Type

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04602065

CIBI318B201

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Previously received anti-PD1/PD-L1 antibodies

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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