The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
NCT Number: NCT05270928
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Suzhou, Jiangsu, 215000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IBI346 Antibody and IBI346 CAR-T cell injection
Time frame: 21 days post IBI346 administration
Time frame: 2 years post IBI346 administration
Time frame: Baseline up to 15 years
Time frame: 3 months post IBI346 administration
Number of patients with a best response of either complete response, stringent complete response, very good partial response or partial response, assessed using modified International Myeloma Working Group response criteria(2016)
Time frame: 2 years post IBI346 administration
DOR will be calculated among responders (with a PR or better response) from the date of initial response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2016).
Time frame: 2 years post IBI346 administration
PFS defined as time from date of initial administration of IBI346 to date of first disease progression according to IMWG criteria (2016), or death due to any cause, whichever occurs first.
Time frame: 2 years post IBI346 administration
OS is measured from the date of the initial administration of IBI346 to the date of the subject's death.
Time frame: 2 years post IBI346 administration
Time frame: 2 years post IBI346 administration
Time frame: 2 years post IBI346 administration
Time frame: 2 years post IBI346 administration
Time frame: 2 years post IBI346 administration
Time frame: 2 years post IBI346 administration
Time frame: 2 years post IBI346 administration
Time frame: 2 years post IBI346 administration
Time frame: 2 years post IBI346 administration
The First Affiliated Hospital of Soochow University
Other
An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myelom
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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