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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

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

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: 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

~2310