Relapsed/Refractory Multiple Myeloma (RRMM)Phase 1NCT07667868
A Phase I, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing BP2202 in people with Relapsed/Refractory Multiple Myeloma (RRMM), run by BrightPath Biotherapeutics Co., Ltd..
Trial summary
The purpose of this study is to find out if BP2202 is safe and can treat participants with Relapsed/Refractory Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma (RRMM)
- What is being tested?
- BP2202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Director contact
About this study
Official title: 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.
Read the 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.
- Being tested
- BP2202
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP2202Biological
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| BP2202 | Experimental | Not described Receives: Biological: BP2202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Up to approximately 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrightPath Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667868
- Sponsor's protocol ID
- BP2202-001
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No