What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, including chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy can cause alopecia, nausea, vomiting, fatigue, and increased infection risk. Targeted therapies, such as small molecule inhibitors and monoclonal antibodies, may result in partial alopecia, hair curling, and dyspigmentation. Immunotherapy, particularly immune checkpoint inhibitors, can lead to patchy hypopigmentation, vitiligo, and alopecia, though these are less common. The severity and frequency of these side effects depend on the specific treatment and patient response.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of Non-Hodgkin's Lymphoma. These include monoclonal antibodies like rituximab, which targets the CD20 antigen on B-cells, and CAR-T cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which modify a patient's T-cells to target CD19 on lymphoma cells. Additionally, small molecule inhibitors like ibrutinib, which inhibits Bruton's tyrosine kinase, and lenalidomide, an immunomodulatory agent, have been approved for certain subtypes of NHL. These therapies represent significant advancements in targeting specific pathways and cells involved in the disease.

What other types of research exist?

Promising novel alternatives to BMS-986458 for Non-Hodgkin's Lymphoma patients include: 1) CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which have shown high efficacy in relapsed/refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target CD19 on B-cells and engage T-cells to kill the cancer cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which deliver cytotoxic agents directly to cancer cells. 4) Novel small molecule inhibitors like venetoclax, which targets BCL-2 and has shown promise in combination therapies for NHL.

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Monoclonal Antibodies

BMS-986458 + Rituximab for Non-Hodgkin Lymphoma

Phase 1 & 2

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 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BMS-986458 to see if it is safe and effective for patients whose non-Hodgkin Lymphoma has come back or didn't respond to other treatments. The study will look at how well the drug works alone and with other cancer-fighting drugs.

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.

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.

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

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

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

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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 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2990

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-Hodgkin's Lymphoma (NHL) treatments often include monoclonal antibodies, chemotherapy, and targeted therapies. Monoclonal antibodies, such as rituximab, target specific proteins on the surface of lymphoma cells, marking them for destruction by the immune system. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancerous lymphocytes. Targeted therapies, like BTK inhibitors (e.g., ibrutinib), interfere with specific molecular pathways crucial for the survival and proliferation of lymphoma cells. Novel agents like BMS-986458 are being studied for their ability to target unique pathways or cellular mechanisms involved in NHL. These treatments are crucial as they offer more precise and potentially less toxic options, improving outcomes and quality of life for NHL patients.