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Not yet recruiting NCT07667868

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

Phase I Interventional Relapsed/Refractory Multiple Myeloma (RRMM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BP2202.
Who it may be relevant to
Registry conditions: Relapsed/Refractory Multiple Myeloma (RRMM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological BP2202
    Intravenous infusion

Primary outcome measures

  • Incidence of dose-limiting toxicities (DLTs; Part A) [Time frame: Up to 4 weeks]
  • Incidence of adverse events (AEs; Parts A and B) [Time frame: Up to approximately 1 year]
Secondary outcome measures (3)
  • 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]
  • Disease Control Rate (DCR) (Parts A and B) [Time frame: Up to approximately 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07667868 · BP2202-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗