New targeted therapy shows promise for Tough-to-Treat lymphomas
NCT ID NCT05453396
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called loncastuximab tesirine in adults with B-cell lymphomas that have returned or not responded to prior treatment. The drug works like a smart bomb, attaching to a marker on cancer cells and delivering chemotherapy directly to them. The main goal is to see how many patients' tumors shrink or disappear. About 20 people will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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11 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female patient aged 18 years or older * Disease-specific criteria: * Group 2: Relapsed/refractory. CD19+ B-cell non-Hodgkin lymphoma (B-NHL) excluding Waldenstrom's macroglobulinemia and marginal zone lymphoma, (at least 1 prior therapy, and no alternative with a more favorable benefit/risk ratio in the judgment of the treating investigator. * Group 3: CD19+ diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL) relapsing after chimeric antigen receptor (CAR) T-cell therapy or allogeneic transplant (at least 30 days from CAR T/transplant) * Have measurable nodal or extranodal disease, including at least 1 disease site measuring 1.5 cm in longest dimension; or splenomegaly; or histologic marrow involvement for marrow-only presentations * Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS) * Absolute neutrophil count (ANC) \>= 1.0 x 10\^3/uL (off growth factors at least 72 hours), unless due to marrow involvement by lymphoma in which case ANC must be \>= 0.5 x 10\^3/uL * Platelet count \>= 75 x 10\^3/uL without transfusion in the prior 7 days, unless due to disease including splenomegaly in which case platelet count must be \>= 50 x 10\^3/uL * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) =\< 3 x the upper limit of normal (ULN) * Total bilirubin =\< 1.5 x ULN (patients with known Gilbert's syndrome may have a total bilirubin up to =\< 3 x ULN) * Blood creatinine =\< 2.0 x ULN or calculated creatinine clearance \>= 50 mL/min by the Cockcroft and Gault equation * Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test within 7 days prior to start of study drug (cycle 1 day 1 \[C1D1\]) for women of childbearing potential * Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of loncastuximab tesirine * Men with female partners who are of childbearing potential must agree that they will use a condom from the time of giving informed consent until at least 7 months after the patient receives his last dose of loncastuximab tesirine Exclusion Criteria: * Previous treatment with loncastuximab tesirine * Known history of hypersensitivity to loncastuximab tesirine * Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy * Uncontrolled graft-versus-host disease * Has known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive or hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] detectable) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected) * Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 9 months after the last dose of trial treatment * Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath) * Lymphoma with active central nervous system (CNS) involvement at the time of screening, including active leptomeningeal disease. A history of treated CNS disease permitted * Significant medical comorbidities, including but not limited to unstable angina, congestive heart failure (New York Heart Association class III or greater), uncontrolled atrial or ventricular cardiac arrhythmia, that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk * Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1) * Use of any other experimental medication within 14 days prior to start of study drug (C1D1) * Planned live vaccine administration after starting study drug (C1D1) * Any other significant medical illness, abnormality, or condition that would, in the investigator's judgment, make the patient inappropriate for study participation or put the patient at risk * Is currently participating in a study and receiving an investigational agent or is using an investigational device within 4 weeks of the first dose of treatment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug combo shield young hearts from transplant complications?
- Could adjusting chemo doses boost CAR T-Cell success against tough lymphoma?
- Radiation boost may supercharge CAR T-Cell therapy against tough lymphoma
- Combination therapy aims to outsmart tough lymphoma
- Targeted drug combo aims to tackle Hard-to-Treat lymphoma