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CAR T-cell Therapy

Zanubrutinib + CAR T-Cell Therapy for Richter's Syndrome

Phase 2

Recruiting

Led By Adam S Kittai, MD

Research Sponsored by Adam Kittai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of drugs to treat Richter's syndrome, a type of cancer of the lymph nodes. The drugs stop abnormal proteins that tell cancer cells to multiply & also change immune cells to attack cancer.

Who is the study for?

Adults with Richter's syndrome, a condition where chronic lymphocytic leukemia transforms into aggressive lymphoma. Participants must have relapsed or refractory disease after at least one treatment cycle, adequate organ function, and meet criteria for CAR T-cell therapy. They should not be pregnant or breastfeeding and must agree to effective contraception.

What is being tested?

The trial is testing the combination of zanubrutinib (a kinase inhibitor that stops cancer cells from multiplying) and lisocabtagene maraleucel (CAR T-cell therapy that modifies patient's immune cells to attack cancer). The goal is to see if this combo is more effective in treating Richter's syndrome.

What are the potential side effects?

Potential side effects include reactions related to infusion, changes in blood counts leading to increased infection risk, fatigue, issues with organs like the heart or liver due to inflammation caused by treatments, and possible complications from modifying the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate

Secondary study objectives

Duration of response

Incidence of adverse events

Overall survival

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (zanubrutinib, liso-cel)Experimental Treatment10 Interventions

Patients receive zanubrutinib PO, undergo leukaphereis, and receive fludarabine IV, cyclophosphamide IV, and liso-cel IV on study. Patients also undergo BM biopsy and lymph node biopsy at screening and follow up, and undergo collection of blood samples and CT, PET/CT, and/or MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~710

Positron Emission Tomography

2011

Completed Phase 2

~2200