Actively Recruiting
Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome
Led by Aseel Alsouqi · Updated on 2026-03-03
24
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
Sponsors
A
Aseel Alsouqi
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well zanubrutinib and lisocabtagene maraleucel (liso-cel) work together in treating patients with Richter's syndrome that has come back (recurrent) or does not respond to treatment (refractory). Richter's syndrome occurs when chronic lymphocytic leukemia and/or small lymphocytic leukemia transforms into an aggressive lymphoma, which is a cancer of the lymph nodes. Zanubrutinib is a class of medication called a kinase inhibitor. These drugs work by preventing the action of abnormal proteins that tell cancer cells to multiply, which helps stop the spread of cancer. Liso-cel is a type of treatment known as chimeric antigen receptor (CAR) T cell therapy. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving zanubrutinib and liso-cell together may kill more cancer cells in patients with recurrent or refractory Richter's syndrome.
CONDITIONS
Official Title
Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Richter's syndrome with diffuse large B-cell lymphoma in patients with prior or concurrent chronic lymphocytic leukemia or small lymphocytic lymphoma
- Relapsed or refractory disease after at least one prior systemic treatment for CLL or Richter's syndrome, or developed Richter's syndrome while on CLL treatment
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Total bilirubin less than or equal to 2 times the institutional upper limit of normal unless Gilbert's syndrome is documented
- AST and ALT less than or equal to 2.5 times the institutional upper limit of normal
- Creatinine clearance of 30 mL/min or higher
- Absolute lymphocyte count greater than 100/uL
- Left ventricular ejection fraction of 40% or higher
- Adequate bone marrow function independent of growth factor or infusion support unless cytopenias are due to marrow involvement by CLL/SLL
- Absolute neutrophil count of at least 1000/mm3 unless lower due to marrow involvement by CLL/SLL, then at least 500
- Platelet count of at least 30,000/mm3 unless lower due to marrow involvement by CLL/SLL
- Hemoglobin level of 7 g/dL or higher unless lower due to marrow involvement by CLL/SLL
- Measurable lymphadenopathy or extra-nodal disease by imaging
- Meet institutional requirements for receiving CAR T-cell therapy
- Ability and willingness to sign informed consent
- Women of childbearing potential must agree to use highly effective contraception or remain abstinent during treatment and for at least 1 year after CAR T-cell infusion or 1 month after last zanubrutinib dose
- Men must agree to use contraception or remain abstinent during treatment and for at least 1 year after CAR T-cell infusion or 1 month after last zanubrutinib dose
You will not qualify if you...
- Prior CD19 directed therapy or alemtuzumab treatment within 6 months
- Prior allogeneic stem cell transplant or donor lymphocyte infusion within 2 months
- Active graft-versus-host disease or recent use of immunosuppressive drugs for GVHD
- Incomplete recovery from prior therapy side effects except certain mild conditions
- Inability to swallow oral medication or significant gastrointestinal disease affecting absorption
- Active bleeding disorders or history of bleeding diathesis
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- Recent gastrointestinal ulcer within 3 months
- Significant heart disease or recent heart attack
- Use of warfarin or similar anticoagulants
- Abnormal blood clotting tests beyond set limits
- Use of moderate or strong CYP3A inhibitors or inducers within 7 days before zanubrutinib
- Active disease or other cancers limiting survival to less than 5 years
- HIV positive status
- Uncontrolled infections, unstable angina, lung problems, or psychiatric/social issues limiting study compliance
- Pregnant or breastfeeding women; women must have negative pregnancy test
- Evidence of myelodysplasia on bone marrow biopsy
- Active hepatitis B or C infection
- Autoimmune disease requiring immunosuppressive medication within 6 months
- Chronic corticosteroid use at 20 mg prednisone equivalent or higher
- Live vaccines given within 28 days before lymphodepleting chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
3
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here