Study on Loncastuximab Tesirine and Rituximab Before CAR T-cell Therapy for Large B-cell Lymphoma
Sponsor: University of Utah
Sponsor score: 0
Inactive
ClinicalTrials ID:NCT06788964
This clinical trial is exploring whether the combination of Loncastuximab Tesirine and Rituximab is safe and effective as a preparatory treatment before standard CAR T-cell therapy in patients with large B-cell lymphoma that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The aim of this study is to determine if using Loncastuximab Tesirine and Rituximab before the standard CAR T-cell therapy is safe and can help treat patients with large B-cell lymphoma that has either come back after treatment or has not responded to previous therapies.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Planned to receive standard CD19-directed CAR T-cell therapy.
- Need additional treatment before CAR T-cell therapy as decided by the doctor.
- Have large B-cell lymphoma that has returned or not responded to at least one previous treatment.
- Have measurable disease as shown by specific imaging tests.
- Be in relatively good health with an ECOG performance status of 0 to 2.
- Meet specific time requirements between previous cancer treatments and the first dose of the study drugs.
- Have adequate organ function, including specific blood counts and liver and kidney function.
- Women must not be pregnant and must meet certain criteria if they are of childbearing potential.
- Agree to use effective contraception if of childbearing potential.
- Be able to understand and sign an informed consent form.
Exclusion Criteria
- Have had previous treatment with any anti-CD19 therapy or CAR T-cell therapy.
- Are receiving investigational CAR T-cell products.
- Have had major surgery within 4 weeks before starting the study.
- Have a history of bleeding disorders or active bleeding.
- Have severe liver disease.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have active graft-versus-host disease.
- Have certain autoimmune diseases or other cancers that may affect safety or participation.
- Have known involvement of the central nervous system by lymphoma.
- Have significant medical conditions that could increase risks or affect participation.
- Have active infections requiring treatment at the time of screening.
- Have HIV infection.
- Have active hepatitis B or C infections unless specific conditions are met.
- Have severe allergies to study drugs or their components.
- Are taking medications that are not allowed during the study.
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