OncoMatch/Clinical Trials/NCT05672251
Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Is NCT05672251 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Loncastuximab Tesirine and Mosunetuzumab for recurrent diffuse large b-cell lymphoma.
Treatment: Loncastuximab Tesirine · Mosunetuzumab — This phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine. Loncastuximab attaches to anti-CD19 cancer cells in a targeted way and delivers tesirine to kill them. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving loncastuximab tesirine with mosunetuzumab may help treat patients with relapsed or refractory diffuse large B-cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 overexpression (positive by immunohistochemistry after the most recent therapy)
Tumor must be positive for both CD19 and CD20 by immunohistochemistry after the most recent therapy.
Required: CD20 overexpression (positive by immunohistochemistry after the most recent therapy)
Tumor must be positive for both CD19 and CD20 by immunohistochemistry after the most recent therapy.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: loncastuximab tesirine (loncastuximab tesirine)
Prior treatment with loncastuximab tesirine.
Cannot have received: mosunetuzumab or other CD20-directed bispecific antibodies (mosunetuzumab)
Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies.
Cannot have received: allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation.
Cannot have received: monoclonal antibody, radioimmunoconjugate or ADC
Exception: within 2 weeks prior to Day 1 of protocol therapy
Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 2 weeks prior to Day 1 of protocol therapy.
Cannot have received: chemotherapeutic agent or other anti-cancer agent (investigational or otherwise)
Exception: within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of protocol therapy
Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of protocol therapy.
Cannot have received: radiotherapy
Exception: within 2 weeks prior to Day 1 of protocol therapy
Treatment with radiotherapy within 2 weeks prior to Day 1 of protocol therapy.
Cannot have received: autologous stem cell transplantation
Exception: within 30 days prior to Day 1 of protocol therapy
Autologous stem cell transplantation (SCT) within 30 days prior to prior to Day 1 of protocol therapy.
Cannot have received: CAR-T cell therapy
Exception: within 30 days prior to Day 1 of protocol therapy
Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to Day 1 of protocol therapy.
Cannot have received: live vaccine
Exception: within 30 days prior to Day 1 of protocol therapy
Live vaccine within 30 days prior to Day 1 of protocol therapy.
Lab requirements
Blood counts
Without bone marrow involvement: ANC >= 1,000/mm^3 (G-CSF allowed to reach ANC requirement); With bone marrow involvement: no minimum ANC requirement; Platelets >= 75,000/mm^3
Kidney function
Creatinine clearance of >= 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 X ULN (<= 3X ULN if hepatic involvement by lymphoma or Gilbert's disease); AST/ALT <= 2.5 x ULN (<= 5 x ULN if hepatic involvement by lymphoma)
Without bone marrow involvement: Absolute neutrophil count (ANC) >= 1,000/mm^3. (G-CSF is allowed to reach ANC requirement). With bone marrow involvement: no minimum ANC requirement. Platelets >= 75,000/mm^3. Total bilirubin <= 1.5 X ULN. If hepatic involvement by lymphoma, or Gilbert's disease: <= 3X ULN. AST <= 2.5 x ULN. If hepatic involvement by lymphoma: AST <= 5 x ULN. ALT <= 2.5 x ULN. If hepatic involvement by lymphoma: ALT <= 5 x ULN. Creatinine clearance of >= 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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