RecruitingMarginal Zone Lymphoma
Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: University of Miami
You may qualify if…
- ✓ 1. Men and women, aged 18 years or older.
- ✓ 2. Histologically confirmed MZL, including extranodal, nodal, and splenic subtypes.
- ✓ 3. Previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody (cluster of differentiation antigen 20) (either as monotherapy or in combination as chemoimmunotherapy), with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen. Subjects with H. pylori-positive gastric extranodal MZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, subject has histologically confirmed MZL and was subsequently treated with at least 1 line of systemic therapy.
- ✓ 4. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the LDi and ≥ 1.0 cm in the longest perpendicular diameter as assessed by CT or MRI per response criteria for lymphomas.68 Imaging must be conducted within 6 weeks prior to the start of therapy.
- ✓ 1. Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
- ✓ 2. Subjects with skin EMZL (extranodal marginal zone lymphoma) who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that skin lesion measures ≥ 1.5 cm in diameter by tape measure and is documented by photo or there are multiple skin lesions measuring \>1cm in diameter on the body that cannot be incorporated in one radiation field and at least one of them is histologically confirmed as MZL.
- ✓ 3. Subjects with gastric extranodal MZL histologically confirmed and need therapy but do not have measurable disease and in which response to treatment can be assess by multiple random gastric biopsies.
- ✓ 4. Subjects with conjunctival EMZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that conjunctival lesion measures ≥ 1 cm in diameter by tape measure and is documented by photo or there are multiple conjunctival lesions measuring together \>1 5cm that cannot be treated by radiation because of previous radiation therapy, contraindications to radiation and patient refusal to receive radiation therapy. At least one of these lesions needs be histologically confirmed as MZL.
You may not qualify if…
- ✕ 1. Evidence of DLBCL transformation. a. Subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL.
- ✕ 2. History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- ✕ 3. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
- ✕ 4. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
- ✕ 5. Active graft versus host disease.
- ✕ 6. Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of study treatment:
- ✕ 1. \< 10 weeks from completion of any radio- or toxin-immunoconjugates.
- ✕ 2. \< 4 weeks for immunotherapy
Where it's recruiting
Source: ClinicalTrials.gov · NCT05296070 · last updated 2026-09-21