Actively Recruiting
Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma
Led by University of Miami · Updated on 2025-09-30
50
Participants Needed
4
Research Sites
366 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
A
ADC Therapeutics S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research study is to see if loncastuximab tesirine has any benefits at dose levels researchers found acceptable in earlier studies in patients with related forms of immune cell cancers. The researchers want to find out the effects (good and bad) that loncastuximab tesirine has on the participant and the participant's condition.
CONDITIONS
Official Title
Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Histologically confirmed marginal zone lymphoma including extranodal, nodal, and splenic types
- Previously treated with at least one systemic therapy including an anti-CD20 antibody and have documented disease progression or inadequate response
- Radiographically measurable disease or histologically confirmed disease in specified subtypes without measurable lesions
- Willingness to provide a recent or new biopsy tissue sample
- At least one treatment initiation criterion such as multiple nodal sites 3 cm, tumor mass 5 cm, B symptoms, risk of organ compromise, splenomegaly, leukopenia, leukemia, threatened organ function, transfusion requirement, multiple extranodal sites, or disease progression within 24 months after diagnosis
- Life expectancy greater than 3 months
- ECOG performance status 0 to 2
- Adequate blood, liver, and kidney function within 6 weeks prior to therapy
- Willingness to use effective contraception during and after the study according to specified guidelines
You will not qualify if you...
- Evidence or suspicion of transformation to diffuse large B-cell lymphoma
- History of central nervous system lymphoma or leptomeningeal disease
- Concurrent anticancer therapies
- Recent stem cell transplant within specified time frames
- Active graft versus host disease
- Recent use of anticancer or investigational drugs within defined intervals
- Incomplete recovery from toxicity or complications of major surgery
- Unresolved prior treatment toxicities except stable chronic toxicities
- Prior anti-CD19 therapy
- Other malignancies within 3 years except certain cured or noninvasive cancers
- Significant uncontrolled medical conditions including effusions not caused by lymphoma
- Active infections requiring systemic treatment or recent live vaccine exposure
- Known HIV infection or positivity
- Hepatitis B or C infection without proper viral load control
- Severe heart failure or uncontrolled arrhythmia
- Recent stroke, liver cirrhosis, or autoimmune disorders requiring immunosuppression
- Pregnancy or breastfeeding
- Any condition interfering with study participation or data interpretation
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
P
Philip Arlen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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