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

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 28 January 2021


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).

Condition Angiocentric T-cell lymphoma
Treatment IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)
Clinical Study IdentifierNCT04602065
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on28 January 2021


Yes No Not Sure

Inclusion Criteria

Histologically diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria
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
Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously)
With measurable foci, defined as: lymph nodes with long diameters>15mmextra-nodal foci>10mm on CT scan
ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1

Exclusion Criteria

Invasive NK cell leukemia
Primary CNS lymphoma or CNS-involved lymphoma
Patients with hemophagocytic syndrome
Patients with lymphoma invading large pulmonary vessels
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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