Relapsed/Refractory Multiple Myeloma (RRMM)
Conditions
Brief summary
The purpose of this study is to find out if BP2202 is safe and can treat participants with Relapsed/Refractory Multiple Myeloma.
Detailed description
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.
Interventions
BIOLOGICALBP2202
Intravenous infusion
Sponsors
BrightPath Biotherapeutics Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Multiple Myeloma with relapsed or refractory disease. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Adequate organ function. * Have measurable disease
Exclusion criteria
* Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of Multiple Myeloma. * Known second malignancy that is progressing or requires active treatment or may interfere with study endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs; Part A) | Up to 6 weeks | Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to BP2202 |
| Incidence of adverse events (AEs; Parts A and B) | Up to approximately 2 years | Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (Parts A and B) | Up to approximately 2 years | The proportion of participants whose best overall response is Partial Response (PR) or better (PR, VGPR, CR, or sCR) according to IMWG criteria. |
| Duration of Response (DoR) (Parts A and B) | Up to approximately 2 years | The time from the first objective response (sCR, CR, VGPR or PR) to the first documented PD according to IMWG criteria or death. |
| Disease Control Rate (DCR) (Parts A and B) | Up to approximately 2 years | Number of participants who achieved a best response of sCR, CR, VGPR, PR or SD according to IMWG criteria. |
Contacts
CONTACTBP2202 Study team
CONTACTDirector
Outcome results
None listed