NCT04602065

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

November 24, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

September 30, 2020

Last Update Submit

March 12, 2023

Conditions

Extranodal NK/T Cell Lymphoma, Nasal Type

Keywords

ENKTL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • ORR

    After the last subject completed follow-up visit of up to 24 weeks

  • CR/PR

    After the last subject completed follow-up visit of up to 24 weeks

  • DCR

    After the last subject completed follow-up visit of up to 24 weeks

  • TTR2016 criteria.)

    After the last subject completed follow-up visit of up to 24 weeks

  • DOR

    After the last subject completed follow-up visit of up to 24 weeks

  • +3 more secondary outcomes

Study Arms (2)

Previously received anti-PD1/PD-L1 antibodies

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

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

IBI318, 300mg, Q2W, Intravenous influsion.

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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\>15mm，extra-nodal foci\>10mm on CT scan;
  • ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1;

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangdong, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 26, 2020

Study Start

November 24, 2020

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

CN(1)