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CAR T-cell Therapy

Axicabtagene Ciloleucel for Non-Hodgkin's Lymphoma (ZUMA-5 Trial)

Phase 2
Waitlist Available
Research Sponsored by Kite, A Gilead Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma
Individual has follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy (e.g. R-bendamustine, R-CHOP)
Must not have
Histological Grade 3b FL
Transformed follicular lymphoma (FL) or marginal zone lymphoma (MZL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Summary

This trial will enroll 160 adults with relapsed or refractory non-Hodgkin's lymphoma. Subjects will receive axicabtagene ciloleucel, an experimental product made from the subject's own genetically-modified white blood cells. The goal is to determine if the product is safe and effective.

Who is the study for?
Adults with relapsed or refractory indolent Non-Hodgkin Lymphoma, specifically follicular lymphoma or marginal zone lymphoma that worsened after at least two prior treatments. Participants must have measurable disease, no CNS lymphoma involvement, and be able to stop current therapies before leukapheresis. They should be in good physical condition (ECOG 0-1) and not pregnant or breastfeeding.
What is being tested?
The trial is testing axicabtagene ciloleucel, a treatment made from the patient's own genetically modified white blood cells designed to fight cancer. It also involves pre-treatment with Cyclophosphamide and Fludarabine. The goal is to see if this approach is effective (aiming for a 70% response rate) and safe for patients.
What are the potential side effects?
Potential side effects may include immune system reactions, fever, fatigue, neurological events like confusion or seizures, low blood cell counts leading to increased infection risk or bleeding problems, and possible allergic reactions due to the body's response to genetically modified cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymphoma has not affected my brain or spinal cord.
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My lymphoma has worsened after two or more treatments.
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My cancer can be measured by tests.
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I am mostly active and have good kidney, liver, lung, and heart function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is classified as Grade 3b follicular lymphoma.
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My lymphoma has changed from a less aggressive type to a more aggressive one.
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My lymphoma affects my heart or I need urgent cancer treatment.
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I have had a stem cell transplant using my own cells or from a donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 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
Objective response rate per central read
Secondary study objectives
Best Objective Response per Central Read or Investigator Read
CR Rate per central read
Complete response rate among those participants with 3 or more lines of prior therapy
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: axicabtagene ciloleucelExperimental Treatment3 Interventions
Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of CAR transduced autologous T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2320

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
44 Previous Clinical Trials
3,821 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
29 Previous Clinical Trials
3,204 Total Patients Enrolled

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03105336 — Phase 2
Follicular Lymphoma Research Study Groups: axicabtagene ciloleucel
Follicular Lymphoma Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT03105336 — Phase 2
Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03105336 — Phase 2
~5 spots leftby Jan 2025
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