Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID06090539

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

On this page

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

Eligible

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
Not Eligible

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

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

F

First line of the email MUST contain NCT # and Site #.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Discovery of BMS-986458, a Potent and Selective B-Cell Lymphoma 6 Protein Ligand-Directed Degrader, for the Treatment of B-Cell Non-Hodgkin Lymphoma.

Deborah S Mortensen, Hunter P Shunatona, Natalie Holmberg-Douglas...

https://pubmed.ncbi.nlm.nih.gov/41670385