What is the mechanism of action of this treatment?

The most common treatments for Non-Hodgkin's Lymphoma (NHL) often involve monoclonal antibodies and chemotherapy. Loncastuximab Tesirine, for example, is a monoclonal antibody that targets CD19 receptors on the surface of cancer cells, delivering the chemotherapy drug tesirine directly to the tumor, which helps to kill the cancer cells while minimizing damage to healthy cells. Similarly, rituximab targets the CD20 antigen on B-cells, marking them for destruction by the immune system. Bendamustine is a chemotherapy agent that causes DNA damage in cancer cells, leading to cell death. These targeted therapies are crucial for NHL patients as they offer more precise treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common side effects of treatments for Non-Hodgkin's Lymphoma, particularly those involving monoclonal antibodies linked to chemotherapy drugs like Loncastuximab Tesirine, include infusion reactions, cytopenias, infections, fatigue, nausea, and diarrhea. Severe adverse events such as cytokine release syndrome and organ toxicity can also occur, depending on the specific drug and patient condition.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibody therapies for the treatment of Non-Hodgkin's Lymphoma. One notable example is Tisagenlecleucel (Kymriah), a CAR-T cell therapy targeting CD19, which has shown efficacy in relapsed or refractory B-cell NHL. Another example is Rituximab, a monoclonal antibody targeting CD20, which has been widely used in combination with chemotherapy for various types of NHL. These therapies, like Loncastuximab Tesirine, leverage the specificity of monoclonal antibodies to target cancer cells, enhancing the efficacy of the attached cytotoxic agents.

What other types of research exist?

Promising alternatives to Loncastuximab Tesirine for Non-Hodgkin's Lymphoma include Obinutuzumab (GA101), a glycoengineered anti-CD20 monoclonal antibody, and Selinexor, an oral selective inhibitor of nuclear export. Both have shown efficacy in clinical trials for relapsed/refractory NHL. Additionally, novel therapies like CAR T-cell therapies targeting CD19, such as Axicabtagene Ciloleucel and Tisagenlecleucel, are also promising options.

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Monoclonal Antibodies

Loncastuximab Tesirine for B-Cell Lymphoma

Phase 2

Recruiting

Led By Stephen D. Smith

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new treatment called loncastuximab tesirine for patients whose B-cell cancers have returned or don't respond to other treatments. The treatment uses a special protein to find cancer cells and deliver a chemotherapy drug directly to them. Patients receive this treatment periodically and are monitored for several years after treatment. Loncastuximab tesirine has been previously tested in an earlier study for similar conditions.

Who is the study for?

Adults with certain B-cell malignancies that have returned or are treatment-resistant can join this trial. They must be over 18, in fairly good health (ECOG PS 0-2), and have normal-ish liver/blood tests. Specific groups include those with CD19+ lymphoma post-transplant, relapsed/refractory non-Hodgkin's excluding some types, or after CAR T-cell therapy/allogeneic transplant. Women/men of childbearing potential must agree to contraception.

What is being tested?

The trial is testing Loncastuximab Tesirine for shrinking tumors in patients with B-cell malignancies that haven't responded to other treatments. It's a monoclonal antibody targeting CD19 receptors on cancer cells combined with a chemo drug to kill them.

What are the potential side effects?

Possible side effects may include reactions at the infusion site, fatigue, nausea, fever, and low blood cell counts leading to increased infection risk. As it involves chemotherapy linked to an antibody, there might also be typical chemo-related side effects like hair loss.

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

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR)

Secondary study objectives

Clinical benefit rate

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (loncastuximab tesirine)Experimental Treatment1 Intervention

Patients receive loncastuximab tesirine IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Loncastuximab tesirine

FDA approved

Do I qualify?Apply below to find out

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

The most common treatments for Non-Hodgkin's Lymphoma (NHL) often involve monoclonal antibodies and chemotherapy. Loncastuximab Tesirine, for example, is a monoclonal antibody that targets CD19 receptors on the surface of cancer cells, delivering the chemotherapy drug tesirine directly to the tumor, which helps to kill the cancer cells while minimizing damage to healthy cells. Similarly, rituximab targets the CD20 antigen on B-cells, marking them for destruction by the immune system. Bendamustine is a chemotherapy agent that causes DNA damage in cancer cells, leading to cell death. These targeted therapies are crucial for NHL patients as they offer more precise treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.