Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies (NCT05453396) | Clinical Trial Compass
RecruitingPhase 2
Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies
United States20 participantsStarted 2023-08-07
Plain-language summary
This phase II trial tests whether loncastuximab tesirine works to shrink tumors in patients with B-cell malignancies that have come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, called loncastuximab, linked to a chemotherapy drug, called tesirine. Loncastuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them.
Who can participate
Age range18 Years
SexALL
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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 syndr…