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A Phase 1/2, multi-center, Open-label, Dose-finding Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986458, alone and in combination with antilymphoma agents in Subjects with Relapsed/Refractory non-Hodgkin lymphomas (R/R NHL)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506654-20-00
Acronym
CA123-1000
Enrollment
231
Registered
2024-02-20
Start date
2024-03-11
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin Lymphomas

Brief summary

Incidence of adverse events (AEs), Serious adverse events (SAEs), AEs meeting protocol defined dose limiting toxicity (DLT) criteria, AEs leading to discontinuation, and death

Detailed description

Summary measures of BMS-986458 PK parameters, Overall response rate, Duration of response, Time to response, Progression free survival, Overall Survival

Interventions

DRUGB-cell Lymphoma 6 Ligand Directed Degrader (BCL6-LDD)
DRUGRITUXIMAB
DRUGOBINUTUZUMAB
DRUGGLOFITAMAB
DRUGMOSUNETUZUMAB

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events (AEs), Serious adverse events (SAEs), AEs meeting protocol defined dose limiting toxicity (DLT) criteria, AEs leading to discontinuation, and death

Secondary

MeasureTime frame
Summary measures of BMS-986458 PK parameters, Overall response rate, Duration of response, Time to response, Progression free survival, Overall Survival

Countries

France, Germany, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026