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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 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

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.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,824 Previous Clinical Trials
1,913,310 Total Patients Enrolled
Stephen D. SmithPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

Loncastuximab Tesirine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05453396 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (loncastuximab tesirine)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Loncastuximab Tesirine Highlights & Side Effects. Trial Name: NCT05453396 — Phase 2
Loncastuximab Tesirine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05453396 — Phase 2
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