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CAR T-cell Therapy

Axicabtagene Ciloleucel for Non-Hodgkin's Lymphoma (ZUMA-14 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first infusion date up to maximum duration of 32.7 months
Awards & highlights

ZUMA-14 Trial Summary

This trial is testing a new treatment for people with a certain type of lymphoma that has come back or does not respond to other treatments.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

ZUMA-14 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first infusion date up to maximum duration of 32.7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and first infusion date up to maximum duration of 32.7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators
Secondary outcome measures
Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28)
Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators
Level of Anti-CD19 CAR T Cells in Blood by Visit
+7 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%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

ZUMA-14 Trial Design

1Treatment groups
Experimental Treatment
Group I: Axicabtagene Ciloleucel and Rituximab CombinationExperimental Treatment4 Interventions
Participants will receive rituximab 375 mg/m^2, once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m^2 over 30 minutes and cyclophosphamide 500 mg/m^2 over 60 minutes) once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg once on Day 0 and additional rituximab 375 mg/m^2 of 5 doses, once every 28 days starting from Day 21 up to Day 133.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axicabtagene Ciloleucel
2015
Completed Phase 2
~500
Rituximab
1999
Completed Phase 4
~1880
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,629 Total Patients Enrolled
Gilead SciencesLead Sponsor
1,083 Previous Clinical Trials
843,332 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,987 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma
2019. "Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04002401.
~5 spots leftby Apr 2025
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