OncoMatch/Clinical Trials/NCT05464719
A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
Is NCT05464719 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Loncastuximab Tesirine for large b-cell lymphoma.
Treatment: Loncastuximab Tesirine — To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 loss of expression
No evidence of CD19 expression after CAR T-cell therapy infusion is required for enrolment
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CAR-T cell therapy (anti-CD19 autologous CAR T-cell product) — standard of care, outside of a clinical trial
Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial
Cannot have received: CAR-T cell therapy
Exception: standard of care only; prior CAR T-cell therapy on clinical trial is excluded
Treatment with CAR T-cell therapy on clinical trial as immediate treatment before enrollment
Cannot have received: antibody-drug conjugate (loncastuximab tesirine)
Prior treatment with lonca
Lab requirements
Blood counts
Absolute neutrophil count (ANC) of ≥ 1.0×10^9/L without growth factor support for 3 days prior to screening assessment; Platelet count of ≥ 50×10^9/L without transfusion for 3 days prior to screening assessment.
Kidney function
Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min
Liver function
Serum alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN); Total bilirubin ≤2 mg/dL, except in subjects with Gilbert's syndrome.
Cardiac function
Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion
Absolute neutrophil count (ANC) of ≥ 1.0×10^9/L without growth factor support for 3 days prior to screening assessment. Platelet count of ≥ 50×10^9/L without transfusion for 3 days prior to screening assessment. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min. Serum alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN). Total bilirubin ≤2 mg/dL, except in subjects with Gilbert's syndrome. Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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