Trial Title:
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
NCT ID:
NCT06090539
Condition:
Relapsed/Refractory Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Rituximab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMS-986458
Description:
Specified dose on specified days.
Arm group label:
Part A1
Arm group label:
Part A2
Arm group label:
Part B1
Arm group label:
Part B2
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Specified dose on specified days.
Arm group label:
Part A2
Arm group label:
Part B2
Summary:
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 (LDD) of BCL6 (BCL6 LDD), as a single agent
and in combination with anti-lymphoma agents in participants with relapsed/refractory
non-Hodgkin Lymphoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants ≥ 18 years of age with R/R NHL (including DLBCL [ie, DLBCL not
otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell
lymphoma with MYC and BCL2 rearrangements], and FL):
- For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy
(eg, first-line combination chemotherapy regimen containing rituximab,
anthracycline, an alkylating agent, and steroids and at least one additional
treatment).
- For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of
therapy which must have been administered after transformation.
- For R/R FL (except for FL 3b): following at least 2 prior lines of therapy and
meeting treatment criteria at the time of enrollment based on investigator´s
assessment.
- 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.
Exclusion Criteria:
- 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, Cereblon-modulating drug or radiotherapy ≤ 4
weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6
months or autologous SCT ≤ 3 months prior to study intervention initiation.
- Participants must not have any condition, including significant acute or chronic
medical illness, active or uncontrolled infection, or the presence of laboratory
abnormalities, that places participants at unacceptable risk if participating in
this study.
- Participants must not have known or suspected central nervous system involvement.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Comprehensive Cancer Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Avyakta Kallam, Site 0020
Phone:
626-219-9200
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Qualls, Site 0044
Phone:
617-632-6844
Facility:
Name:
Northwell Health/ RJ Zuckerberg Cancer Center
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan Kolitz, Site 0047
Phone:
516734-8970
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Lue, Site 0046
Phone:
917-887-8514
Facility:
Name:
Hopital Claude Huriez - CHU de Lille
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Recruiting
Contact:
Last name:
Franck Morschhauser, Site 0003
Phone:
33320445713
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Contact:
Last name:
Vincent Ribrag, Site 0001
Phone:
33142114507
Facility:
Name:
CHU SAINT ELOI-Département d'Hématologie Clinique
Address:
City:
Montpellier
Zip:
34295
Country:
France
Status:
Recruiting
Contact:
Last name:
Guillaume Cartron, Site 0005
Phone:
+33675926918
Facility:
Name:
Institut Claudius Regaud
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Loïc Ysebaert, Site 0002
Phone:
33531156351
Facility:
Name:
Universitätsklinikum Münster - Albert Schweitzer Campus
Address:
City:
Münster
Zip:
48149
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Andrea Kerkhoff, Site 0049
Phone:
+492518346010
Facility:
Name:
Universitaetsklinikum des Saarlandes
Address:
City:
Homburg
Zip:
66424
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Joerg Bittenbring, Site 0050
Phone:
4968411615000
Facility:
Name:
Universitätsklinikum Leipzig
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Vladan Vucinic, Site 0029
Phone:
493419713841
Facility:
Name:
Helios Klinikum Berlin-Buch
Address:
City:
Berlin
Zip:
13125
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Snjezana Janjetovic, Site 0051
Phone:
+49 30 9401-12104
Facility:
Name:
Maastricht UMC+
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marjolein Van der Poel, Site 0052
Phone:
+31433877026
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marcel Nijland, Site 0053
Phone:
050-3616161
Facility:
Name:
Hospital Universitario Virgen de la Victoria
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Antonio Rueda Dominguez, Site 0007
Phone:
607847416
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pablo Abrisqueta Costa, Site 0041
Phone:
34932746000X4975
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Miguel Canales Albendea, Site 0018
Phone:
34 948 396 297
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Raul Cordoba Mascuñano, Site 0006
Phone:
+34649694829
Facility:
Name:
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alejandro Martin García-Sancho, Site 0019
Phone:
34923291100
Facility:
Name:
Ospedale Regionale Bellinzona e Valli
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Anastasios Stathis, Site 0033
Phone:
41918118931
Facility:
Name:
University Hospital Basel
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Fatime Krasniqi, Site 0032
Phone:
41612655074
Facility:
Name:
Hôpitaux Universitaire de Genève
Address:
City:
Genève
Zip:
1211
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Noemie Lang, Site 0048
Phone:
+41795532406
Start date:
December 29, 2023
Completion date:
October 28, 2028
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090539
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
http://www.BMSClinicalTrials.com
