OncoMatch/Clinical Trials/NCT05453396
Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies
Is NCT05453396 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Loncastuximab Tesirine for post-transplant lymphoproliferative disorder.
Treatment: Loncastuximab Tesirine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 positive
Group 1: CD19+ relapsed/refractory post-transplant lymphoproliferative disorder (PTLD)
Required: CD19 positive
Group 2: Relapsed/refractory. CD19+ B-cell non-Hodgkin lymphoma (B-NHL) excluding Waldenstrom's macroglobulinemia and marginal zone lymphoma
Required: CD19 positive
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
Required: CD19 negative (minimal to absent expression by both immunohistochemistry and flow cytometry) (minimal to absent)
Group 4: Relapsed/refractory, CD19-negative B-NHL by both immunohistochemistry and flow cytometry (minimal to absent expression)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received:
at least 1 prior therapy
Must have received: CAR-T cell therapy
relapsing after chimeric antigen receptor (CAR) T-cell therapy
Must have received: allogeneic transplant
relapsing after ... allogeneic transplant
Cannot have received: (loncastuximab tesirine)
Previous treatment with loncastuximab tesirine
Lab requirements
Blood counts
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
Kidney function
Blood creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 50 mL/min by Cockcroft and Gault equation
Liver function
ALT, AST, and GGT ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if Gilbert's syndrome)
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; ALT, AST, and GGT ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if Gilbert's syndrome); Blood creatinine ≤ 2.0 x ULN or calculated creatinine clearance ≥ 50 mL/min by Cockcroft and Gault equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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