The purpose of this study is to find out if BP2202 is safe and can treat participants with Relapsed/Refractory Multiple Myeloma.
Part A of the study will evaluate the safety and tolerability of BP2202 and determine recommended phase 2 dose. Part B of the study will further evaluate safety and explore the potential anti-myeloma activity of BP2202 at recommended phase 2 dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Intravenous infusion
Incidence of dose-limiting toxicities (DLTs; Part A)
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to BP2202
Time frame: Up to 6 weeks
Incidence of adverse events (AEs; Parts A and B)
Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)
Time frame: Up to approximately 2 years
Overall Response Rate (Parts A and B)
The proportion of participants whose best overall response is Partial Response (PR) or better (PR, VGPR, CR, or sCR) according to IMWG criteria.
Time frame: Up to approximately 2 years
Duration of Response (DoR) (Parts A and B)
The time from the first objective response (sCR, CR, VGPR or PR) to the first documented PD according to IMWG criteria or death.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) (Parts A and B)
Number of participants who achieved a best response of sCR, CR, VGPR, PR or SD according to IMWG criteria.
Time frame: Up to approximately 2 years
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