Actively Recruiting
Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation
Led by City of Hope Medical Center · Updated on 2025-12-15
20
Participants Needed
2
Research Sites
170 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well adding lisocabtagene maraleucel (liso-cel) to nivolumab and ibrutinib works in treating patients with Richter's transformation. Liso-cel is in a class of medications called autologous cellular immunotherapy, a type of medication prepared by using cells from patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells and other substances that cause disease) to fight the cancer cells. Nivolumab is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the grown of cancer. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Giving ibrutinib and nivolumab with Liso-cel may kill more cancer cells in patients with Richter's transformation.
CONDITIONS
Official Title
Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent
- Agree to a pre-treatment tumor biopsy or provide acceptable archival biopsy material
- Age 18 years or older
- ECOG performance status of 2 or less
- Histologically confirmed Richter's Transformation
- Relapsed or refractory after at least 2 prior systemic therapies, or meet other specified relapse/refractory criteria
- Eligible to receive liso-cel and ibrutinib according to package guidelines
- Fully recovered from prior anti-cancer therapy toxic effects except alopecia (Grade 1 or less)
- Absolute neutrophil count (ANC) of 750/mm^3 or higher unless bone marrow involved
- Platelet count of 75,000/mm^3 or higher unless bone marrow involved
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), unless Gilbert's disease
- AST and ALT less than or equal to 2.5 times ULN
- Creatinine clearance of 30 mL/min or higher
- INR or Prothrombin time less than or equal to 1.5 times ULN
- aPTT less than or equal to 1.5 times ULN
- Left ventricular ejection fraction (LVEF) of 40% or higher within 28 days prior to treatment
- Seronegative for active hepatitis C, hepatitis B, and syphilis or have undetectable viral load if positive
- Meet institutional and federal infectious disease titer requirements
- Women of childbearing potential have negative pregnancy test
- Agree to use effective birth control or abstain from heterosexual activity during study and for 5 months after last dose
You will not qualify if you...
- Prior treatment with PD-1 or PD-L1 inhibitors
- Autologous stem cell transplant within 3 months before starting study treatment
- Allogeneic stem cell transplant within 3 months without active graft versus host disease or immunosuppressant need
- Chemotherapy, radiation, or immunotherapy within 14 days before study treatment
- Use of strong CYP3A inducers within 14 days before study treatment
- Use of warfarin within 5 days before study treatment
- Current need for oxygen supplementation
- Use of systemic steroids or chronic immunosuppressants (except low-dose or inhaled steroids under specified conditions)
- Lymphoma involving only the central nervous system
- Class III/IV cardiovascular disability or unstable arrhythmias
- History of optic neuritis or other immunologic/inflammatory CNS diseases
- Allergic reactions to similar compounds
- Known bleeding disorders
- Stroke or intracranial hemorrhage within 6 months before screening
- Recent other malignancies except certain treated or localized cancers
- Clinically significant uncontrolled illness or active infection
- Known HIV infection
- Pregnant or breastfeeding females
- Active autoimmune disease except certain controlled conditions
- Any condition judged unsafe or incompatible with study participation
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
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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