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Monoclonal Antibodies

Loncastuximab Tesirine for Marginal Zone Lymphoma

Phase 2
Recruiting
Led By Izidore Lossos, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody, with documented progression or failure to achieve CR or PR after the most recent systemic treatment regimen
Subjects with conjunctival EMZL must have conjunctival lesion measures ≥ 1 cm in diameter or multiple lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing if a new cancer drug is effective and safe for people with certain types of immune cell cancer.

Who is the study for?
This trial is for adults over 18 with Marginal Zone Lymphoma who've had at least one prior systemic therapy including an anti-CD20 antibody. They should have measurable disease or specific criteria met for non-measurable disease, and be able to undergo biopsies if needed. Key exclusions include recent cancer treatments, other malignancies within the last 3 years, certain heart conditions, liver cirrhosis, autoimmune disorders requiring strong immunosuppression, active infections or HIV/HBV/HCV infection.Check my eligibility
What is being tested?
The study tests two doses of Loncastuximab tesirine (150 µg/Kg and 75µg/Kg) in patients with relapsed/refractory Marginal Zone Lymphoma to evaluate its effectiveness and safety. It's an open-label trial meaning everyone knows which treatment they're getting.See study design
What are the potential side effects?
Potential side effects of Loncastuximab tesirine may include symptoms related to infusion reactions like fever or chills, fatigue, changes in blood counts leading to increased risk of infections or bleeding problems, liver enzyme alterations suggesting possible liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had treatment including an anti-CD20 antibody for my condition but it didn't fully work.
Select...
I have a conjunctival eye lesion that is at least 1 cm wide or I have multiple lesions.
Select...
My cancer is a type of marginal zone lymphoma.
Select...
My cancer can be seen on scans.
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My skin lesion is at least 1.5 cm wide or I have multiple skin lesions.
Select...
My stomach cancer's type and stage are confirmed by biopsy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
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I am willing to undergo a biopsy of my lymph node or tissue.
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My spleen cancer has spread to my bone marrow, confirmed by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 12 months
Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 6 months
Secondary outcome measures
Duration of Response (DOR)
Number of Treatment Related Toxicities
Overall response rate (ORR) at 12 months
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Loncastuximab tesirine Cycles 1-6Experimental Treatment2 Interventions
Patients will be treated with loncastuximab tesirine for a total of 6 cycles on Day 1 (+/-3) of each 21 day (3 week) cycle. The total duration of treatment is approximately 18 weeks (4.5 months)

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,209 Total Patients Enrolled
ADC Therapeutics S.A.Industry Sponsor
28 Previous Clinical Trials
2,183 Total Patients Enrolled
Izidore Lossos, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

Loncastuximab Tesirine (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05296070 — Phase 2
Marginal Zone Lymphoma Research Study Groups: Loncastuximab tesirine Cycles 1-6
Marginal Zone Lymphoma Clinical Trial 2023: Loncastuximab Tesirine Highlights & Side Effects. Trial Name: NCT05296070 — Phase 2
Loncastuximab Tesirine (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05296070 — Phase 2

Frequently Asked Questions

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

How many participants are enrolled in this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this medical investigation is still enrolling participants since it was first posted on June 21st 2022 and updated most recently on July 12th 2022. It seeks out 50 individuals from a single research site."

Answered by AI

What is the ultimate purpose of this clinical research project?

"The trial's primary outcome of loncastuximab tesirine in those with relapsed/refractory cancer will be evaluated over the course of 12 months. This assessment will include an overall response rate (CR+PR) and partial response rates determined by Cheson or revised Lugano criteria (based on PET avidity). Secondary objectives are also established, such as measuring complete and partial responses per modified MZL at 6 and 12 months respectively."

Answered by AI

Is admission to the trial still open for volunteers?

"According to clinicaltrials.gov, this medical trial is actively seeking qualified participants. It was initially announced on June 21st 2022 and recently modified on July 12th 2022."

Answered by AI

Is Loncastuximab tesirine 150 µg/Kg a secure medication for patients?

"The safety of Loncastuximab tesirine 150 µg/Kg has been rated a 2 by our Power team, as there is some evidence to suggest it's safe but no data that can confirm its efficacy."

Answered by AI
~27 spots leftby May 2026