Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
NCT Number: NCT07764861
This is an open-label, multi-center phase II study of IBI3003 in combination with anti-CD38 monoclonal antibody in adult subjects with multiple myeloma. This study includes a safety run-in period and 2 cohorts (Cohorts 1 and 2).In the safety run-in period, subjects with measurable relapsed or refractory multiple myeloma who had previously received at least 1 line of systemic anti-myeloma therapy and had a history of dual drug exposure (at least one proteasome inhibitor and one immunomodulatory agent) were enrolled, mainly to evaluate the safety and tolerability of IBI3003 in combination with anti-CD38 monoclonal antibody and to determine the recommended phase 2 dose of IBI3003 in combination with anti-CD38 monoclonal antibody.Cohort 1 mainly enrolls newly diagnosed MM(Multiple myeloma)patients who are ineligible for or refusing ASCT(Autologous Stem Cell Transplantation), and Cohort 2 enrolls newly diagnosed MM patients who are eligible for and willing to undergo ASCT. The 24-week MRD negative rate of IBI3003 in combination with anti-CD38 monoclonal antibody in the participant population is mainly evaluated.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, 100044, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Note: Refractory to antimyeloma therapy requires failure to achieve minimal response (receipt of at least 2 complete cycles) or progression during treatment (no requirement for number of treatment cycles), or progression within 60 days of last treatment.
Cohort 1: Participants with newly diagnosed multiple myeloma who are ineligible for or refusing ASCT.
Cohort 2: Participants with newly diagnosed multiple myeloma who are eligible for and interested in ASCT.
Exclusion criteria
A potent synthetic glucocorticoid
Recombinant humanized anti-GPRC5D/BCMA/CD3 trispecific antibody injection
An Oral Immunomodulator And Antineoplastic Drug
Anti-cancer monoclonal antibody targeting CD38
Time frame: 24weeks
Defined as the percentage of participants who achieved MRD-negative status at or below the threshold of 10-5 at any time after the first treatment.
Time frame: 30Days
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 30Days
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 30Days
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 30Days
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 3years
FPS is defined as the time from the date of randomization to the date of the first documented progression or death due to any case ,whichever occurs first
Time frame: 3years
Defined as the proportion of participants achieving sCR, CR, VGPR, or PR according to the IMWG criteria
Time frame: 12Months
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 12Months
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 12Months
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 12Months
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Contact information is provided by the study sponsor or research team.
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Multi-Center, Open-Label Phase II Study of IBI3003 in Combination With Anti-CD38 Monoclonal Antibody in Participants With Multiple Myeloma
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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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