Phase II Study of Loncastuximab Tesirine for Patients with Large B-Cell Lymphoma After CAR T-Cell Therapy

Inclusion Criteria

• Have relapsed or refractory large B-cell lymphoma, including specific subtypes like primary mediastinal B-cell lymphoma.
• Have received standard CAR T-cell therapy approved by the FDA, not as part of a clinical trial.
• Be 18 years or older.
• Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
• Have achieved a partial response 30 days after CAR T-cell therapy according to specific criteria.
• At least 30 days must have passed since receiving CAR T-cell therapy.
• No evidence of CD19 expression after CAR T-cell therapy is required for enrollment.
• Have not received any additional anti-cancer treatment after CAR T-cell therapy, except for palliative radiotherapy.
• Have specific blood counts and organ function levels within normal ranges.
• Have a heart function of at least 45% and normal oxygen levels.
• No active lymphoma in the central nervous system.
• Women of childbearing potential must have a negative pregnancy test and use effective contraception.
• Any previous side effects from CAR T-cell therapy must have resolved to a specific level.

Exclusion Criteria

• Have significant fluid buildup in the body that requires drainage.
• Have had another type of cancer within the last year, except for certain skin or in situ cancers.
• Have a history of Richter's transformation of chronic lymphocytic leukemia.
• Have received CAR T-cell therapy as part of a clinical trial immediately before this study.
• Have been treated with lonca before.
• Have an uncontrolled infection or require IV antibiotics.
• Have a known history of HIV or hepatitis B or C, unless the viral load is undetectable.
• Have active heart involvement by lymphoma or significant heart disease within the last year.
• Have a primary immunodeficiency or autoimmune disease requiring treatment in the last two years.
• Have had a significant blood clot within the last month.
• Have any medical condition that might interfere with the study.
• Have a severe allergic reaction to any study drugs.
• Women who are pregnant or breastfeeding.
• Not willing to use birth control during and after the study.
• Unlikely to complete all study visits or follow the study requirements.