← Back to Search

Monoclonal Antibodies

BMS-986458 + Rituximab for Non-Hodgkin Lymphoma

Phase 1

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial will assess a new drug for non-Hodgkin Lymphoma, assessing safety, effectiveness, and tolerability.

Who is the study for?

This trial is for people with Non-Hodgkin Lymphoma who have tried at least two prior treatments. They must have a type of lymphoma that shows up on certain body scans and agree to follow a pregnancy prevention plan.Check my eligibility

What is being tested?

The study tests BMS-986458, both alone and combined with other anti-lymphoma drugs like Rituximab, to see how safe it is and if it works against relapsed/refractory non-Hodgkin Lymphoma.See study design

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, changes in blood counts, fatigue, nausea, fever, rash or itching. Each person's reaction to the treatment can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had at least 2 treatments for my lymphoma, including chemotherapy with rituximab.

Select...

I have had at least 2 treatments for my transformed lymphoma.

Select...

I have at least one tumor that can be measured and is larger than 1.5 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with AEs leading to death

Number of participants with AEs leading to discontiunation

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

+2 more

Secondary outcome measures

Area under the plasma concentration-time curve (AUC(0-T))

Duration of response (DOR)

Maximum concentration (Cmax)

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part B2Experimental Treatment2 Interventions

Combination Treatment

Group II: Part B1Experimental Treatment1 Intervention

Single Agent

Group III: Part A2Experimental Treatment2 Interventions

Combination Treatment

Group IV: Part A1Experimental Treatment1 Intervention

Single Agent

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,791 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Section A1 of the FDA been ratified?

"Part A1's safety is rated a 1, as this trial stands at Phase 1 and has limited scientific evidence to support its efficacy or security."

Answered by AI

Are there any open slots for those wishing to participate in this experiment?

"Per clinicaltrials.gov, this study is no longer actively enrolling participants as it was initially published on November 20th of 2021 and last updated on October 13th of the same year. Nevertheless, there are 1,754 other trials in search for candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06090539.