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A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

ConditionRelapsed/Refractory Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader of B-cell lymphoma 6 (BCL6), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants ≥ 18 years of age with frontline or R/R NHL.

Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion > 1.5 cm in the transverse diameter).

Participants must accept and follow pregnancy prevention plan.

Disqualifiers

Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

Participants with an inability to comply with listed restrictions, precautions and prohibited treatments.

Participants must not have prior CAR-T, or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months (only applicable to BMS-986458 single agent or rituximab combination cohorts), or autologous SCT ≤ 3 months prior to study intervention initiation.

In BMS-986458 + T-cell engager combination cohorts: Participants must not have prior alloSCT or solid organ transplantation, history of confirmed progressive multifocal leukoencephalopathy (PML); known or suspected history of hemophagocytic lymphohistiocytosis (HLH); known or suspected chronic active Epstein-Barr (EBV) infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • BMS-986458

    Drug

    Specified dose on specified days.

  • Rituximab

    Drug

    Specified dose on specified days.

  • Glofitamab/Obinutuzumab

    Drug

    Specified dose on specified days

  • Mosunetuzumab

    Drug

    Specified dose on specified days

  • Epcoritamab

    Drug

    Specified dose on specified days

  • Golcadomide

    Drug

    Specified dose on specified days

Treatment groups

460 Participants
are divided into 5 treatment groups
Group A: Part A1Experimental treatment 1 intervention
Group B: Part A2Experimental treatment 4 interventions
Group C: Part B1Experimental treatment 1 intervention
Group D: Part B2Experimental treatment 5 interventions
Group E: Part B3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to 2 years and 1 month
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to 2 years and 1 month
3

Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

Time frame
Up to Day 28
4

Number of participants with AEs leading to death

Time frame
Up to 2 years and 1 month

Secondary outcomes

1

Maximum concentration (Cmax)

Time frame
Up to 4 months
2

Time of maximum concentration (Tmax)

Time frame
Up to 4 months
3

Area under the plasma concentration-time curve within a dosing interval [AUC(TAU)]

Time frame
Up to 4 months
4

Number of participants with a complete response rate (CRR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by Investigator assessment

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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