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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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
Peking University People's Hospital
Beijing, Beijing Municipality, China
MRD( Minimal Residue Disease) negativity rate at 24 weeks
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: 24weeks
AE(Adverse event)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 30Days
TEAE(Treatment emergent adverse event)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 30Days
SAE(Serious Adverse Event)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 30Days
AESI( Adverse event of special interest)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 30Days
Progression-Free Survival (PFS)
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
ORR(objective response rate)
Defined as the proportion of participants achieving sCR, CR, VGPR, or PR according to the IMWG criteria
Time frame: 3years
AE(Adverse event)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 12Months
TEAE(Treatment emergent adverse event)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 12Months
SAEs(serious adverse events)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 12Months
AESI( Adverse event of special interest)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE V5.0
Time frame: 12Months
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