Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Location status: Recruiting
NCT Number: NCT07081022
To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, 100142, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients must meet all of the following inclusion criteria to be enrolled:
Exclusion criteria
Gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W until progression or unacceptable toxicity.
Ifosfamide, carboplatin and etoposide, 3 cycles (Q3W) and JS203, Cycle 1 QW, Cycle 2 and therafter Q3W until trasnplant, progression or unacceptable toxicity.
Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone 6 cycles (Q3W) and JS203, 8 cycles (21 days/cycle), Cycle 1 QW, Cycle 2 to Cycle 8 Q3W.
lenalidomide,12 cycles, Cycle 1(Q3W), Cycle 2 to Cycle 12 (Q4W) and JS203, 12 cycles, Cycle 1 (21 days/cycle) QW, Cycle 2 to Cycle 12 (28 days/cycle) Q4W.
Time frame: up to approximately 15 months
Objective response rate (ORR) based on 2014 Lugano criteria
Time frame: up to approximately 24 months
The complete response rate (CR) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 24 months
Duration of response (DoR) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 24 months
Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 24 months
Time to response (TTR) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 24 months
Progression-free survival (PFS) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 24 months
Overall survival (OS) evaluated based on 2014 Lugano criteria
Time frame: up to approximately 24 months
Incidence and severity of all adverse events (AE) that occurred during the clinical trial
Time frame: up to approximately 24 months
The serum drug concentration of JS203
Time frame: up to approximately 24 months
The incidence and titer of the anti-drug antibody (ADA) of JS203
Time frame: Up to approximately 24 months
The incidence of neutralizing antibodies (NAb) of JS203 (if applicable)
Contact information is provided by the study sponsor or research team.
Shanghai Junshi Bioscience Co., Ltd.
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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