A Phase 1/2 Study to Evaluate the Safety and Effects of BMS-986458 Alone and With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Led by Bristol-Myers Squibb · Updated on 2026-04-14
308
Participants Needed
65
Research Sites
52 weeks
Total Duration
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AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
AI-Summary
What this Trial Is About
Researchers are evaluating BMS-986458, a drug designed to target B-cell lymphoma 6 (BCL6), in people with relapsed or refractory non-Hodgkin lymphoma (NHL). This study aims to understand the safety, tolerability, drug levels, and early biological and clinical effects of BMS-986458 alone and combined with other anti-lymphoma treatments. The trial is sponsored by Bristol-Myers Squibb and includes adults aged 18 and older with specific types of NHL.
Participants receive BMS-986458 either by itself or in combination with other drugs such as Rituximab, Glofitamab/Obinutuzumab, or Mosunetuzumab. The dosing schedule is specified for each drug and may vary depending on the treatment group. The study includes multiple parts with different treatment approaches to find the best dose and combination for treating lymphoma.
During the study, participants will be closely monitored for adverse events, drug levels in the blood, and lymphoma response using established criteria. Assessments include safety evaluations up to 2 years and 1 month, and measuring treatment responses and survival outcomes for up to 3 years. This long-term follow-up helps researchers understand how well the treatments work and their safety over time.
CONDITIONS
Brief Title
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Adults aged 18 years or older with relapsed or refractory non-Hodgkin lymphoma, including specific subtypes such as diffuse large B-cell lymphoma and follicular lymphoma
For certain subtypes, participants must have had at least two prior lines of therapy
Measurable disease present with at least one lesion larger than 1.5 cm confirmed by imaging
Participants must agree to and follow a pregnancy prevention plan
You will not qualify if you...
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher
Unable to comply with study restrictions, precautions, or prohibited treatments
Prior CAR-T therapy or recent radiotherapy within 4 weeks before starting the study
Recent systemic anticancer treatment within 5 half-lives or 4 weeks before the study
Recent allogeneic stem cell transplant within 6 months (for certain cohorts)
Recent autologous stem cell transplant within 3 months before study start
For combination cohorts, prior allogeneic stem cell or solid organ transplant, history of progressive multifocal leukoencephalopathy, hemophagocytic lymphohistiocytosis, or chronic active Epstein-Barr virus infection
Any significant acute or chronic illness, active or uncontrolled infection, or lab abnormalities posing unacceptable risk
Known or suspected involvement of the central nervous system with lymphoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 years and 1 month
Participants receive BMS-986458 alone or in combination with anti-lymphoma agents as specified doses on specified days.
Visits occur according to dosing schedule throughout treatment period
Follow-up
Duration - Up to 3 years
Participants are monitored for safety and treatment effects after completing treatment.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 65 locations
1
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
3
Local Institution - 0068
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Local Institution - 0014
Fairway, Kansas, United States, 66205
Not Yet Recruiting
6
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Local Institution - 0124
Omaha, Nebraska, United States, 68105
Not Yet Recruiting
9
Local Institution - 0047
Lake Success, New York, United States, 11042
Completed
10
Local Institution - 0037
New York, New York, United States, 10016
Not Yet Recruiting
11
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
12
Local Institution - 0040
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
13
Local Institution - 0045
Providence, Rhode Island, United States, 02903
Not Yet Recruiting
14
Local Institution - 0024
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
15
Local Institution - 0118
Antofagasta, AN, Chile, 1240000
Not Yet Recruiting
16
Local Institution - 0105
Santiago, Metropolitana de Santiago, Chile, 7580206
Not Yet Recruiting
17
Local Institution - 0109
Santiago, Santiago Metropolitan, Chile, 8420383
Not Yet Recruiting
18
Local Institution - 0088
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
19
Local Institution - 0089
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
20
Local Institution - 0084
Guangzhou, China, 510060
Not Yet Recruiting
21
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, France, 33076
Actively Recruiting
22
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France, 59000
Actively Recruiting
23
Gustave Roussy
Villejuif, Paris, France, 94800
Actively Recruiting
24
Henri Mondor Hospital
Créteil, Val-de-Marne, France, 94010
Actively Recruiting
25
CHU SAINT ELOI - Departement Hematologie Clinique
Montpellier, France, 34295
Actively Recruiting
26
Hôpital Saint-Louis
Paris, France, 75010
Actively Recruiting
27
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
28
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
29
Universitaetsklinikum des Saarlandes
Homburg, Saarland, Germany, 66424
Actively Recruiting
30
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
31
Helios Klinikum Berlin-Buch
Berlin, Germany, 13125
Actively Recruiting
32
Local Institution - 0070
Essen, Germany, 45147
Not Yet Recruiting
33
Local Institution - 0103
Pátrai, Achaḯa, Greece, 26504
Not Yet Recruiting
34
Local Institution - 0106
Alexandroupoli, Evros, Greece, 68100
Not Yet Recruiting
35
Local Institution - 0107
Athens, Greece, 10676
Not Yet Recruiting
36
Local Institution - 0102
Athens, Greece, 11 527
Not Yet Recruiting
37
Local Institution - 0094
Bologna, Italy, 40138
Not Yet Recruiting
38
Local Institution - 0116
Brescia, Italy, 25123
Not Yet Recruiting
39
Local Institution - 0098
Milan, Italy, 20132
Not Yet Recruiting
40
Local Institution - 0113
Milan, Italy, 20133
Not Yet Recruiting
41
Local Institution - 0112
Pisa, Italy, 56126
Not Yet Recruiting
42
Local Institution - 0111
Ravenna, Italy, 48121
Not Yet Recruiting
43
Local Institution - 0115
Roma, Italy, 00144
Not Yet Recruiting
44
Local Institution - 0110
Roma, Italy, 00168
Not Yet Recruiting
45
Local Institution - 0097
Verona, Italy, 37134
Not Yet Recruiting
46
Local Institution - 0090
Nagoya, Aichi-ken, Japan, 4668560
Not Yet Recruiting
47
Local Institution - 0091
Chuo-ku, Tokyo, Japan, 104-0045
Not Yet Recruiting
48
Local Institution - 0086
Chūō, Yamanashi, Japan, 4093898
Not Yet Recruiting
49
Local Institution - 0092
Fukuoka, Japan, 812-8582
Not Yet Recruiting
50
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
51
Local Institution - 0121
Amsterdam, North Holland, Netherlands, 1981 HV
Not Yet Recruiting
52
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
53
Local Institution - 0077
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Not Yet Recruiting
54
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain, 29010
Actively Recruiting
55
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
56
Local Institution - 0069
Madrid, Madrid, Comunidad de, Spain, 28009
Not Yet Recruiting
57
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
58
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
59
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
60
Ospedale Regionale Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
61
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
62
Hopitaux Universitaires de Geneve (HUG)
Geneva, Switzerland, 1205
Actively Recruiting
63
Local Institution - 0071
Southampton, Hampshire, United Kingdom, SO16 0YD
Not Yet Recruiting
64
Local Institution - 0081
Manchester, Lancashire, United Kingdom, M20 4BX
Not Yet Recruiting
65
Local Institution - 0072
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Not Yet Recruiting
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Research Team
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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First line of the email MUST contain NCT # and Site #.