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

June 19, 2026 updated by: BrightPath Biotherapeutics Co., Ltd.

A Phase I, Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients[尚小1.1] 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BP2202
Biological: BP2202
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 4 weeks
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)
Up to approximately 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (Parts A and B)
Time Frame: Up to approximately 1 year
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.
Up to approximately 1 year
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.
Up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrightPath Biotherapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2043

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP2202-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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