A Phase I, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to find out if BP2202 is safe and can treat participants with Relapsed/Refractory Multiple Myeloma.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Relapsed/Refractory Multiple Myeloma (RRMM) Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BP2202

Biological

Intravenous infusion

Primary outcomes

Incidence of dose-limiting toxicities (DLTs; Part A)

Time frame: Up to 4 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)

Time frame: Up to approximately 1 year

Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)

Secondary outcomes

Overall Response Rate (Parts A and B)

Time frame: Up to approximately 1 year
Duration of Response (DoR) (Parts A and B)

Time frame: Up to approximately 1 year

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)

Time frame: Up to approximately 1 year

Number of participants who achieved a best response of sCR, CR, VGPR, PR or SD according to IMWG criteria.

Sponsors and collaborators

Lead sponsor

BrightPath Biotherapeutics Co., Ltd.

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Jun 25, 2026
Registry last updated: Jul 1, 2026

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.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting