This is a multicenter, single-arm phase II study to evaluate the efficacy and safety of CS1001 monotherapy for relapsed/refractory classical Hodgkin Lymphoma (rr-cHL)
Eligible subjects with rr-cHL who failed at least two prior lines of therapies are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Monoclonal antibody
Beijing Cancer Hospital
Beijing, China
Objective response rate (ORR)
The percentage of subjects whose best overall response is either complete response or partial response evaluated by IRRC according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification
Time frame: From first patient first visit to 6 month after last patient first visit
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