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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrightPath Biotherapeutics Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • BP2202

    Biological/Vaccine

    Intravenous infusion

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: BP2202Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 6 weeks
2

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)

Time frame
Up to approximately 2 years

Secondary outcomes

1

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.

Time frame
Up to approximately 2 years
2

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.

Time frame
Up to approximately 2 years
3

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.

Time frame
Up to approximately 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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