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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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lymphoma affects my brain or spinal cord.My white blood cell count is within the required range.I have been treated with loncastuximab tesirine before.I am 18 years old or older.I plan to get a live vaccine after starting the study drug.My kidney function, measured by creatinine levels or clearance, is within the required range.I have another type of cancer besides non-aggressive skin, prostate, cervical, or certain breast cancers.My B-cell lymphoma has returned or didn't respond to treatment, and I've tried at least one therapy.I agree to use a condom for 7 months after my last dose of the treatment.I have fluid buildup needing drainage or causing breathing issues.I have ongoing issues with graft-versus-host disease.My condition meets the specific criteria for my disease.My B-cell NHL has come back or didn't respond to treatment and lacks CD19.I can take care of myself and am up and about more than half of my waking hours.I haven't had major surgery or cancer treatment in the last 14 days.My condition is CD19+ PTLD and it has come back or didn't respond after a transplant.I have a cancerous area or spleen enlargement that can be measured.My lymphoma returned after CAR T-cell therapy or a transplant.I have active hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (loncastuximab tesirine)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.