Clinical trial
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
Name
CIBI318B201
Description
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).
Trial arms
Trial start
2020-11-24
Estimated PCD
2023-02-28
Trial end
2023-02-28
Status
Terminated
Phase
Early phase I
Treatment
IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)
IBI318, 300mg, Q2W, Intravenous influsion.
Arms:
Patients previously never received anti-PD1/PD-L1 antibodies, Previously received anti-PD1/PD-L1 antibodies
Size
9
Primary endpoint
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
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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}
Updated at
2023-03-15
1 organization
1 product
2 indications
Organization
Innovent Biologics (Suzhou)Product
IBI318Indication
Extranodal NK/T Cell LymphomaIndication
Nasal Type