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CAR T-cell Therapy

Axicabtagene Ciloleucel for Large B-Cell Lymphoma (ZUMA-11 Trial)

Phase 1
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
Diffuse large B cell lymphoma (DLBCL) not otherwise specified (ABC/GCB)
High grade B-cell lymphoma (HGBCL) with or without MYC and BCL2 and/or BCL6 rearrangement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

ZUMA-11 Trial Summary

This study is evaluating whether a new type of cancer treatment is safe and effective.

Eligible Conditions
  • Large B-Cell Lymphoma

ZUMA-11 Trial Eligibility Criteria

Inclusion Criteria

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

ZUMA-11 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
For Phase 1: Percentage of Participants Experiencing Adverse Events defined as Dose Limiting Toxicities (DLTs)
For Phase 2: Complete Response Rate
Secondary outcome measures
For Phase 1 and Phase 2: Duration of Response
For Phase 1 and Phase 2: Objective Response Rate
For Phase 1 and Phase 2: Overall Survival
+5 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%
Diarrhoea
31%
Hypokalaemia
31%
Tachycardia
27%
Back pain
27%
Constipation
27%
Hypophosphataemia
23%
White blood cell count decreased
23%
Tremor
23%
Platelet count decreased
23%
B-cell lymphoma
23%
Dizziness
19%
Agitation
19%
Cough
19%
Hypogammaglobulinaemia
19%
Tachypnoea
19%
Oedema peripheral
19%
Neutropenia
19%
Hyponatraemia
15%
Hypomagnesaemia
15%
Dysphagia
15%
Dyspnoea
15%
Chills
15%
Thrombocytopenia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
12%
Aspartate aminotransferase increased
12%
Hypoxia
12%
Myalgia
12%
Malaise
12%
Abdominal pain
12%
Pain
12%
Hypertension
12%
Peripheral sensory neuropathy
12%
Vomiting
12%
Arthralgia
12%
Covid-19
12%
Hyperglycaemia
8%
Pancytopenia
8%
Dysuria
8%
Hyperhidrosis
8%
Lymphocyte count decreased
8%
Gait disturbance
8%
Pneumonia
8%
Sepsis
8%
Oral candidiasis
8%
Muscular weakness
8%
Encephalopathy
8%
Somnolence
8%
Blood creatinine increased
8%
Urinary tract infection
8%
Acute myeloid leukaemia
8%
Eye pain
8%
Aphasia
8%
Asthenia
8%
Insomnia
4%
Syncope
4%
Depression
4%
Covid-19 pneumonia
4%
Embolism
4%
Pleural effusion
4%
Febrile neutropenia
4%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

ZUMA-11 Trial Design

1Treatment groups
Experimental Treatment
Group I: Axicabtagene ciloleucel plus utomilumabExperimental Treatment4 Interventions
Phase 1: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by axicabtagene ciloleucel treatment on Day 0 plus utomilumab on study Day 1 or study Day 21 and continuing once every 4 weeks (Q4W) for 6 months or until Progressive Disease, whichever comes first. Phase 2: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by axicabtagene ciloleucel and utomilumab based on the dose/regimen selected to move forward from the Phase 1 portion of the study as recommended by the internal Safety Review Team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Utomilumab
2018
Completed Phase 2
~30
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1090
Axicabtagene Ciloleucel
2015
Completed Phase 2
~500

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,636 Total Patients Enrolled
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,667 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,994 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025