Actively Recruiting
Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL)
Led by University of Utah · Updated on 2025-12-03
29
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
A
ADC Therapeutics S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to learn if the study treatment Loncastuximab tesirine and Rituximab is safe and efficient before standard of care chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory large B-cell lymphoma.
CONDITIONS
Official Title
Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Planned to receive commercial CD19-directed CAR-T cell therapy (axi-cel or liso-cel)
- Need for bridging therapy as determined by the treating physician
- Diagnosed with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), primary mediastinal B-cell lymphoma (PMBCL), or high-grade B-cell lymphoma (HGBL) per 2016 WHO classification
- Disease relapsed or refractory after at least one multi-agent systemic therapy
- Measurable disease by PET-CT, CT, or MRI as defined by 2014 Lugano Classification
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Sufficient time elapsed since prior anticancer therapies (30 days for autologous transplant, 60 days for allogeneic transplant, 21 days for cytotoxic chemotherapy, 14 days for non-cytotoxic chemotherapy)
- Adequate organ function including blood counts, liver and kidney function within specified limits
- For females of childbearing potential, negative pregnancy test and agreement to use effective contraception
- Ability to read, understand, and provide informed consent
- Willingness to comply with study requirements and restrictions
You will not qualify if you...
- Previous treatment with any anti-CD19 therapy including Loncastuximab Tesirine or prior CD19 CAR-T therapy
- Receiving investigational CAR-T products
- Major surgery within 4 weeks before starting study treatment
- History of bleeding disorders or active bleeding
- Chronic liver disease with severe impairment (Child-Pugh class C)
- Pregnant, lactating, or planning pregnancy during the study
- Active graft-versus-host disease or post-transplant lymphoproliferative disorder
- Active autoimmune disease that may affect safety or study participation
- Diagnosis of another malignancy that may interfere with safety or participation
- Known central nervous system involvement
- Significant medical conditions increasing risk, such as severe heart failure, recent heart attack, prolonged QT interval, severe lung disease, uncontrolled diabetes, severe immune compromise
- Active systemic infections requiring treatment at screening
- HIV infection
- Active hepatitis B infection; hepatitis B core antibody positive without prophylaxis; active hepatitis C under therapy
- Known severe allergic reaction to CD19 antibody, Loncastuximab Tesirine, or related components
- Use of prohibited medications without appropriate washout period before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
R
Rachel Kingsford
CONTACT
N
Narendranath Epperla, MD, MS, FACP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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