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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07667868
- Acronym / sponsor ID
- BP2202-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- BrightPath Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BP2202 | Experimental | Biological: BP2202 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP2202Intravenous infusion | Biological | BP2202 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs; Part A)
Time frame: 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)
Time frame: Up to approximately 2 years
Number of participants who experienced AEs, adverse events of special interest (AESIs), or serious adverse events (SAEs)
3 secondary outcomes
Overall Response Rate (Parts A and B)
Time frame: Up to approximately 2 years
Duration of Response (DoR) (Parts A and B)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) (Parts A and B)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Director contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BP2202 in people with Relapsed/Refractory Multiple Myeloma (RRMM), run by BrightPath Biotherapeutics Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BP2202 Study team (+81358407679, bp2202-001@brightpathbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs; Part A) (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.