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CAR T-cell Therapy

Axicabtagene Ciloleucel for Follicular Lymphoma (ZUMA-22 Trial)

Phase 3

Recruiting

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

Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy

Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)

Must not have

Neuropathy greater than grade 2

Females who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is comparing a new treatment to the current standard of care for people with a certain type of lymphoma that has come back or doesn't respond to treatment. They will be looking at how well the new treatment works compared to the current standard by measuring how long people live without the disease getting worse.

Who is the study for?

This trial is for adults with a confirmed diagnosis of follicular lymphoma who need treatment and have at least one measurable lesion. They must have had the disease return or not respond after initial therapy, including those whose disease came back within 24 months or after two treatments. Pregnant women, individuals with certain nervous system disorders, severe neuropathy, active infections (including HIV and hepatitis), autoimmune diseases, cardiac issues in the past six months, prior CD19-targeted therapies or CAR T-cell therapies cannot participate.

What is being tested?

The study is testing axicabtagene ciloleucel against standard care drugs like Vincristine, Prednisone, Bendamustine etc., to see which works better for relapsed/refractory follicular lymphoma. Participants will be randomly assigned to receive either the study drug or one of the standard care options.

What are the potential side effects?

Axicabtagene ciloleucel may cause immune system reactions that can affect different body parts leading to symptoms like fever and fatigue; it might also lead to low blood cell counts increasing infection risk. Standard care drugs can cause hair loss, nausea/vomiting, weakness and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer returned or didn't respond after initial treatment and it's considered high-risk.

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My lymphoma is confirmed as follicular and is either grade 1, 2, or 3a.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe nerve pain or numbness.

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I am not pregnant or breastfeeding.

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My condition is Follicular Lymphoma Grade 3b.

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I do not have an active infection with HIV, hepatitis B, or hepatitis C.

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I have previously received treatment targeting CD19.

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My lymphoma affects my heart.

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I have a significant brain or nerve condition.

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I have large B cell lymphoma or transformed follicular lymphoma.

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I do not have any untreated infections.

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I am not willing to use birth control.

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I have not had CAR T-cell therapy or any genetically modified T-cell treatment.

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My lymphoma has spread through the entire thickness of my stomach wall.

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I have a medical tube or drain in my body, but ports like Port-a-Cath are okay.

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I have a history of CNS lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification

Secondary study objectives

Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)

Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)

Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30

+10 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401

88%

Pyrexia

65%

Neutrophil count decreased

62%

Nausea

58%

Hypotension

50%

Anaemia

46%

Headache

38%

Fatigue

38%

Decreased appetite

35%

Confusional state

31%

Tachycardia

31%

Diarrhoea

31%

Hypokalaemia

27%

Constipation

27%

Hypophosphataemia

27%

Back pain

23%

Dizziness

23%

Tremor

23%

B-cell lymphoma

23%

Platelet count decreased

23%

White blood cell count decreased

19%

Cough

19%

Agitation

19%

Hyponatraemia

19%

Neutropenia

19%

Tachypnoea

19%

Hypogammaglobulinaemia

19%

Oedema peripheral

15%

Hypomagnesaemia

15%

Thrombocytopenia

15%

Dysphagia

15%

Alanine aminotransferase increased

15%

Sinus tachycardia

15%

Chills

15%

Dyspnoea

12%

Aspartate aminotransferase increased

12%

Pain

12%

Arthralgia

12%

Myalgia

12%

Hypertension

12%

Hyperglycaemia

12%

Hypoxia

12%

Vomiting

12%

Abdominal pain

12%

Peripheral sensory neuropathy

12%

Covid-19

12%

Malaise

Dysuria

Muscular weakness

Blood creatinine increased

Hyperhidrosis

Insomnia

Acute myeloid leukaemia

Encephalopathy

Sepsis

Pancytopenia

Eye pain

Lymphocyte count decreased

Asthenia

Urinary tract infection

Somnolence

Oral candidiasis

Pneumonia

Gait disturbance

Aphasia

Pleural effusion

Depression

Embolism

Syncope

Respiratory failure

Febrile neutropenia

Covid-19 pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

Axicabtagene Ciloleucel and Rituximab Combination

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Axicabtagene CiloleucelExperimental Treatment3 Interventions

Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepleting chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10\^8 anti-CD19 CAR T cells will be administered.

Group II: Standard of Care TherapyActive Control7 Interventions

Participants will receive the investigator's choice of one of the following therapies/dosing schedules: * Rituximab plus lenalidomide (R\^2) for 12 cycles (28-day cycle) * Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m\^2 on Day 1, Day 8, Day 15, and Day 22 * Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1 * Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21 * Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle) * rituximab 375 mg/m\^2 on Day 1 * cyclophosphamide 750 mg/m\^2 on Day 1 * doxorubicin 50 mg/m\^2 on Day 1 * vincristine 1.4 mg/m\^2 (maximum 2 mg) on Day 1 * prednisone 40 mg/m\^2 on Day 1 through Day 5 * Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle) * rituximab 375 mg/m\^2 on Day 1 * bendamustine 90 mg/m\^2 on Day 1 and Day 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axicabtagene Ciloleucel

2020

Completed Phase 2

~510

Cyclophosphamide

2010

Completed Phase 4

~2310