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CAR T-cell Therapy
Zanubrutinib + CAR T-Cell Therapy for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Led By Reem Karmali, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patients must have a histo-pathologically confirmed diagnosis of an aggressive B-cell non-Hodgkin lymphoma or transformed indolent B-cell lymphoma that is recurrent or refractory to standard therapy and with intent to treat with standard of care CAR T-cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying 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.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from the therapy administration, possible digestive disturbances due to medication intake, and an increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
Select...
My aggressive B-cell lymphoma is not responding to standard treatments and I am considered for CAR T-cell therapy.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in 6-month complete response rates
Secondary outcome measures
Conversion rates of partial response (PR) to CR
Incidence of adverse events
Overall response rate (ORR)
+2 moreOther outcome measures
CAR T cell polyfunctionality
Changes in immune cell subsets and cytokines
Disease-specific symptoms and/or treatment-related concerns
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (zanubrutinib and CAR T-cell therapy)Experimental Treatment4 Interventions
LEAD- IN PHASE: Patients receive zanubrutinib PO BID for 7-14 days in the absence of disease progression or unacceptable toxicity.
CAR T-CELL THERAPY: Patients receive standard of care CAR T-cell therapy IV at 4 weeks.
MAINTENANCE PHASE: Patients receive zanubrutinib PO BID on days 1-28. Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,619 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,207 Total Patients Enrolled
Reem Karmali, MDPrincipal InvestigatorNorthwestern University
4 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active disease in my brain or spinal cord.I cannot swallow pills or capsules.I agree to use effective birth control during and for 6 months after the study.I have taken a pregnancy test in the last 28 days and it was negative.I do not have stomach or intestine problems that affect medication absorption.I am able to get out of my bed or chair and move around.My aggressive B-cell lymphoma is not responding to standard treatments and I am considered for CAR T-cell therapy.I have hepatitis B but minimal liver damage and my virus is undetectable with treatment.I haven't taken strong medication that affects liver enzymes in the last week.I haven't taken steroids or immunosuppressants in the last 7 days.My kidneys are functioning well enough, as per a recent test.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (zanubrutinib and CAR T-cell therapy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current sample size of this medical experiment?
"To complete this trial, 24 individuals who meet the eligibility requirements must enrol. Specifically, participants can come from Northwestern University in Chicago and Medical College of Wisconsin located in Milwaukee."
Answered by AI
To what degree can Chimeric Antigen Receptor T-Cell Therapy be considered a secure treatment for individuals?
"Through careful review, our team at Power assigned Chimeric Antigen Receptor T-Cell Therapy a score of 2 on a scale from 1 to 3; this is due the Phase 2 status and lack of efficacy data."
Answered by AI
Are there opportunities for patients to join this experiment?
"Affirmative. The information accessible on clinicaltrials.gov demonstrates that the trial, first uploaded to the database in March of 2022, continues to actively recruit participants. 24 patients are required from 3 distinct venues for this study."
Answered by AI
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