24 Participants Needed

Zanubrutinib + CAR T-Cell Therapy for Non-Hodgkin's Lymphoma

Recruiting at 2 trial locations
SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies the effect of zanubrutinib and CAR T-cell therapy in treating patients with aggressive B-cell non-Hodgkin's lymphoma or transformed indolent B-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CAR, a protein on the surface of cancer cells. These CAR-specific T cells may help the body's immune system identify and kill cancer cells. Giving zanubrutinib together with CAR T-cell therapy may kill more cancer cells.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot take certain medications like moderate or strong CYP3A inducers or high-dose corticosteroids shortly before starting the trial. It's best to discuss your current medications with the trial team.

What is the safety profile of CAR T-cell therapies like axicabtagene ciloleucel and tisagenlecleucel?

CAR T-cell therapies, such as axicabtagene ciloleucel and tisagenlecleucel, have been associated with some serious side effects, including cytokine release syndrome (a severe immune reaction) and neurological issues. These side effects are generally manageable with proper medical care, but they can require hospitalization and intensive monitoring.12345

What makes the treatment Zanubrutinib + CAR T-Cell Therapy unique for Non-Hodgkin's Lymphoma?

This treatment combines Zanubrutinib, a drug that targets specific proteins in cancer cells, with CAR T-cell therapy, which uses modified immune cells to attack cancer. This combination aims to enhance the effectiveness of treatment for aggressive B-cell lymphomas, especially when other options have failed.678910

What data supports the effectiveness of the treatment Zanubrutinib + CAR T-Cell Therapy for Non-Hodgkin's Lymphoma?

CAR T-cell therapies like axicabtagene ciloleucel and tisagenlecleucel have shown to improve outcomes for patients with aggressive B-cell lymphomas that are resistant to other treatments. These therapies have been approved for use in patients with relapsed or refractory large B-cell lymphoma, demonstrating their effectiveness in targeting and eliminating cancerous B cells.2481011

Who Is on the Research Team?

Reem Karmali, MD, MS: Robert H. Lurie ...

Reem Karmali

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Adults with certain aggressive B-cell non-Hodgkin's lymphoma or transformed indolent B-cell lymphoma that is resistant to standard treatments. Participants must have a life expectancy over 12 weeks, acceptable organ function, and no active infections or severe heart conditions. Pregnant women, nursing mothers, HIV patients, and those unable to swallow pills are excluded.

Inclusion Criteria

I agree to use effective birth control during and for 6 months after the study.
Patients must have a life expectancy of greater than 12 weeks
Ability to understand and the willingness to sign a written informed consent document
See 10 more

Exclusion Criteria

I have active disease in my brain or spinal cord.
I cannot swallow pills or capsules.
I do not have stomach or intestine problems that affect medication absorption.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in Phase

Participants receive zanubrutinib orally twice daily for 7-14 days

1-2 weeks
1 visit (in-person)

CAR T-Cell Therapy

Participants receive standard of care CAR T-cell therapy intravenously

4 weeks
1 visit (in-person)

Maintenance Phase

Participants receive zanubrutinib orally twice daily on days 1-28, with cycles repeating every 28 days for 12 months

12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Chimeric Antigen Receptor T-Cell Therapy
  • Zanubrutinib
Trial Overview The trial studies the combination of zanubrutinib (a drug blocking enzymes for cell growth) with CAR T-cell therapy (patient's T cells engineered to target cancer cells). It aims to see if this combo is more effective in treating specific types of recurrent or unresponsive B-cell lymphomas.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (zanubrutinib and CAR T-cell therapy)Experimental Treatment4 Interventions

Chimeric Antigen Receptor T-Cell Therapy is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Tisagenlecleucel for:
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Approved in United States as Tisagenlecleucel for:
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Approved in European Union as Axicabtagene ciloleucel for:
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Approved in United States as Axicabtagene ciloleucel for:
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Approved in European Union as Tecartus for:
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Approved in United States as Tecartus for:
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Approved in European Union as Brexucabtagene autoleucel for:
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Approved in United States as Brexucabtagene autoleucel for:
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Approved in European Union as Lisocabtagene maraleucel for:
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Approved in United States as Lisocabtagene maraleucel for:
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Approved in Canada as CAR T-cell therapy for:
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Approved in Japan as CAR T-cell therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

CAR T-cell therapies have significantly changed treatment options for patients with relapsed or refractory aggressive B-cell lymphomas, with three products currently approved or nearing approval.
Selecting the right CAR T-cell product for a patient involves careful consideration of various factors, including the patient's age, health status, previous treatments, and the specific characteristics of each CAR T-cell product.
Patient selection for chimeric antigen receptor (CAR) T-cell therapy for aggressive B-cell non-Hodgkin lymphomas.Johnson, PC., Abramson, JS.[2021]
CAR-T cell therapies, specifically axicabtagene ciloleucel and tisagenlecleucel, have significantly improved outcomes for patients with relapsed or refractory aggressive B-cell lymphomas, with approvals based on pivotal trials demonstrating their efficacy after multiple prior treatments.
Despite their similar CAR technologies, differences in manufacturing and clinical trial designs exist between these therapies, highlighting the need for ongoing monitoring of patient responses and potential long-term side effects in real-world settings.
Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials.Westin, JR., Kersten, MJ., Salles, G., et al.[2022]
The three CAR-T cell therapies (axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel) show promising efficacy in treating large B cell lymphoma, with overall response rates of nearly 70% and complete response rates exceeding 50% across 33 studies involving 2,172 patients.
However, axicabtagene ciloleucel and tisagenlecleucel are associated with significant risks of severe neurotoxicity and life-threatening cytokine release syndrome, necessitating careful monitoring during treatment.
Efficacy and Safety of CAR-T Cell Products Axicabtagene Ciloleucel, Tisagenlecleucel, and Lisocabtagene Maraleucel for the Treatment of Hematologic Malignancies: A Systematic Review and Meta-Analysis.Meng, J., Wu, X., Sun, Z., et al.[2022]

Citations

Patient selection for chimeric antigen receptor (CAR) T-cell therapy for aggressive B-cell non-Hodgkin lymphomas. [2021]
Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials. [2022]
Efficacy and Safety of CAR-T Cell Products Axicabtagene Ciloleucel, Tisagenlecleucel, and Lisocabtagene Maraleucel for the Treatment of Hematologic Malignancies: A Systematic Review and Meta-Analysis. [2022]
CD19 chimeric antigen receptor-T cells in B-cell leukemia and lymphoma: current status and perspectives. [2022]
Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. [2019]
Safety profile of chimeric antigen receptor T-cell immunotherapies (CAR-T) in clinical practice. [2021]
Chimeric Antigen Receptor-T Cell Therapy: Practical Considerations for Implementation in Europe. [2020]
Beyond CAR T-Cell Therapy: Continued Monitoring and Management of Complications. [2021]
CAR T-cell therapy for B-cell lymphomas: clinical trial results of available products. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
CAR T-cell therapy for B-cell lymphoma. [2022]
The promise of CAR T-cell therapy in aggressive B-cell lymphoma. [2021]
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