Who is sponsoring NCT04314843?

NCT04314843 is sponsored by Kite, A Gilead Company.

What drugs are being tested in NCT04314843?

Interventions in NCT04314843: Cyclophosphamide, Fludarabine, Lenzilumab, Axicabtagene Ciloleucel.

What condition does NCT04314843 study?

NCT04314843 studies Relapsed/Refractory Large B-cell Lymphoma.

Is NCT04314843 still recruiting?

NCT04314843 is currently terminated. Last updated 4 March 2024.

Are results published for NCT04314843?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-04 · How we verify

NCT04314843: ZUMA-19

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma

Terminated Phase 1 Results posted Last updated 4 March 2024

What this trial tests

Phase 1 trial testing Cyclophosphamide in Relapsed/Refractory Large B-cell Lymphoma in 6 participants. Terminated before completion.

Timeline

26 May 2020

Primary endpoint
16 March 2021

27 July 2022

Quick facts

Lead sponsor	Kite, A Gilead Company
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	26 May 2020
Primary completion	16 March 2021
Estimated completion	27 July 2022
Sites	10 locations across United States

Drugs / interventions tested

Cyclophosphamide (cyclophosphamide) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Lenzilumab — full drug profile →
Axicabtagene Ciloleucel — full drug profile →

Conditions studied

Relapsed/Refractory Large B-cell Lymphoma — all drugs for Relapsed/Refractory Large B-cell Lymphoma →

Sponsor

Kite, A Gilead Company — full company profile →

Who can join

18 and older, any sex, with Relapsed/Refractory Large B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phase 1: Percentage of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy With Lenzilumab and Axicabtagene Primary · First infusion of lenzilumab and axicabtagene ciloleucel up to 28 days.

A DLT was defined as the following sequenced therapy-related events with onset within the first 28 days following lenzilumab and axicabtagene ciloleucel infusions: * Grade 4 neutropenia lasting longer than 21 days from the day of cell transfer * Grade 4 thrombocytopenia lasting longer than 28 days from the day of cell transfer * Any sequenced therapy-related AE requiring intubation, including Grade 4 encephalopathy requiring intubation for airway protection * Any sequenced therapy-related Grade 5 event

Group	Value	95% CI
Phase 1/Cohort 1	0
Phase 1/Cohort 2	0

Phase 1 and Phase 2: Percentage of Participants Experiencing Adverse Events Secondary · Enrollment through 3 months after lenzilumab and axicabtagene ciloleucel infusion.

Group	Value	95% CI
Phase 1/Cohort 1	100
Phase 1/Cohort 2	100

Phase 1 and Phase 2: Percentage of Participants Experiencing Serious Adverse Events Secondary · Enrollment through 3 months after lenzilumab and axicabtagene ciloleucel infusion.

Group	Value	95% CI
Phase 1/Cohort 1	67
Phase 1/Cohort 2	100

Phase 1 and Phase 2: Percentage of Participants Experiencing Cytokine Release Syndrome Secondary · Enrollment through 12 months after lenzilumab and axicabtagene ciloleucel infusion or until disease progression, whichever occurred first.

Group	Value	95% CI
Phase 1/Cohort 1	67
Phase 1/Cohort 2	67

Phase 1 and Phase 2: Percentage of Participants Experiencing Neurologic Events Secondary · Enrollment through 12 months after lenzilumab and axicabtagene ciloleucel infusion or until disease progression, whichever occurred first.

Group	Value	95% CI
Phase 1/Cohort 1	100
Phase 1/Cohort 2	67

Phase 1 and Phase 2: Complete Response (CR) Rate Per Internal Working Group (IWG) Lugano Classification as Determined by the Study Investigators Secondary · First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

CR rate: percentage of participants with CR (CMR;CRR). CMR: positron emission tomography(PET)5-point scale(5PS) scores of 1(no uptake above background), 2(uptake ≤ mediastinum), 3(uptake \> mediastinum but ≤ liver) with/without a residual mass); no new sites; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter (LDi) of a lesion; no extra lymphatic sites; absent non-measured lesion;organ enlargement regress to normal; no new sites; and bone marrow normal by morphology.

Group	Value	95% CI
Phase 1/Cohort 1	67	9 – 99
Phase 1/Cohort 2	67	9 – 99

Phase 1 and Phase 2: Objective Response Rate (ORR) Per IWG Lugano Classification as Determined by Study Investigators Secondary · First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

ORR: Percentage of participants with CR(CMR;CRR) or PR(partial metabolic response(PMR);partial radiologic response (PRR)).CMR:PET 5PS scores of 1,2,3 with/without a residual mass;no new sites;no evidence of FDG-avid disease in bone marrow.CRR:target nodes/nodal masses regressed to ≤ 1.5 cm in LDi of a lesion;no extra lymphatic sites;absent non-measured lesion;organ enlargement regress to normal;no new sites;bone marrow normal by morphology.PMR:5PS scores of 4(uptake moderately higher than liver),or 5(uptake markedly higher than liver and/or new lesions),with reduced uptake compared to baseline

Group	Value	95% CI
Phase 1/Cohort 1	67	9 – 99
Phase 1/Cohort 2	100	29 – 100

Phase 1 and Phase 2: Duration of Response (DOR) in Participants Who Experience an Objective Response Per IWG Lugano Classification as Determined by Study Investigators Secondary · First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

DOR is defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and is the time from the first objective response to disease progression or death from any cause. Objective response is defined in outcome measure (OM) 7.

Group	Value	95% CI
Phase 1/Cohort 1	9.9	NA – NA
Phase 1/Cohort 2	12.1	2.7 – NA

Phase 1 and Phase 2: Progression-Free Survival (PFS) Per IWG Lugano Classification as Determined by Study Investigators Secondary · First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause.

Group	Value	95% CI
Phase 1/Cohort 1	10.8	0.9 – NA
Phase 1/Cohort 2	13.0	3.6 – NA

Phase 1 and Phase 2: Overall Survival (OS) Secondary · First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

OS is defined as the time from axicabtagene ciloleucel infusion to the date of death.

Group	Value	95% CI
Phase 1/Cohort 1	10.8	4.6 – NA
Phase 1/Cohort 2	13.0	3.6 – NA

Phase 1 and Phase 2: Pharmacodynamics: Peak Serum Level of CXCL10, Granzyme B, IFN-gamma, IL-1 RA, IL-2, IL-6, IL-8, TNF Alpha, GM-CSF, and MCP-1 Secondary · Baseline up to Week 4

Peak is defined as the maximum post-baseline level of the analyte from baseline to Week 4.

CXCL10

Group	Value	95% CI
Phase 1/Cohort 1	2000.00	1474.50 – 2000.00
Phase 1/Cohort 2	809.40	448.60 – 1298.10

Granzyme B

Group	Value	95% CI
Phase 1/Cohort 1	14.50	9.20 – 44.20
Phase 1/Cohort 2	11.80	2.60 – 17.80

IFN-gamma

Group	Value	95% CI
Phase 1/Cohort 1	1238.30	90.60 – 1426.00
Phase 1/Cohort 2	45.70	7.50 – 151.50

IL-1 RA

Group	Value	95% CI
Phase 1/Cohort 1	4984.00	4038.00 – 6187.00
Phase 1/Cohort 2	919.00	701.00 – 1099.00

IL-2

Group	Value	95% CI
Phase 1/Cohort 1	11.80	6.30 – 22.70
Phase 1/Cohort 2	18.20	2.50 – 21.10

IL-6

Group	Value	95% CI
Phase 1/Cohort 1	22.50	8.00 – 976.00
Phase 1/Cohort 2	13.10	3.00 – 15.40

IL-8

Group	Value	95% CI
Phase 1/Cohort 1	56.70	12.90 – 75.70
Phase 1/Cohort 2	31.50	15.40 – 39.90

TNF alpha

Group	Value	95% CI
Phase 1/Cohort 1	5.50	3.40 – 16.50
Phase 1/Cohort 2	3.00	1.70 – 3.30

Phase 1 and Phase 2: Axicabtagene Ciloleucel Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood Secondary · Baseline up to Month 3

Peak is defined as the maximum number of CAR T cells in blood measured after the axicabtagene ciloleucel infusion.

Group	Value	95% CI
Phase 1/Cohort 1	74.28	± 97.60
Phase 1/Cohort 2	20.35	± 15.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events: Enrollment through 3 months after lenzilumab and axicabtagene ciloleucel infusion. All-Cause Mortality: Enrollment up to 22.5 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1/Cohort 1

Serious: 2/3 (67%)

Deaths: 2/3

Phase 1/Cohort 2

Serious: 3/3 (100%)

Deaths: 2/3

Serious adverse events (14 terms)

Reaction	System	Phase 1/Cohort 1	Phase 1/Cohort 2
Encephalopathy	Nervous system disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Pyrexia	General disorders	—	—
Covid-19	Infections and infestations	—	—
Covid-19 pneumonia	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Platelet count decreased	Investigations	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—
Aphasia	Nervous system disorders	—	—
Disturbance in attention	Nervous system disorders	—	—
Agitation	Psychiatric disorders	—	—
Hypertension	Vascular disorders	—	—
Hypotension	Vascular disorders	—	—

Other adverse events (61 terms — click to expand)

Reaction	System	Phase 1/Cohort 1	Phase 1/Cohort 2
Neutropenia	Blood and lymphatic system disorders	—	—
Neutrophil count decreased	Investigations	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Malaise	General disorders	—	—
Pyrexia	General disorders	—	—
Encephalopathy	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Tremor	Nervous system disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—
Bradycardia	Cardiac disorders	—	—
Sinus arrhythmia	Cardiac disorders	—	—
Supraventricular extrasystoles	Cardiac disorders	—	—
Ventricular arrhythmia	Cardiac disorders	—	—
Adrenal insufficiency	Endocrine disorders	—	—
Dry eye	Eye disorders	—	—
Photophobia	Eye disorders	—	—
Vision blurred	Eye disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Pain	General disorders	—	—
Tenderness	General disorders	—	—
Candida infection	Infections and infestations	—	—
Cytomegalovirus infection reactivation	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Skin infection	Infections and infestations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	—	—
Diffuse large B-cell lymphoma refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cognitive disorder	Nervous system disorders	—	—

Most-reported serious reactions: Encephalopathy, Anaemia, Pyrexia, Covid-19, Covid-19 pneumonia, Pneumonia, Platelet count decreased, Hyponatraemia.

Data from ClinicalTrials.gov NCT04314843 adverse events section.

Sponsor's own description

The primary objectives of this study are: Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most appropriate dose of lenzilumab for Phase 2. Phase 2: To evaluate the incidence of neurologic events with sequenced therapy given at the recommended Phase 2 dose (RP2D) of lenzilumab in participants with relapsed or refractory large B-cell lymphoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

2021 Update on Diffuse large B cell lymphoma: A review of current data and potential applications on risk stratification and management.
Susanibar-Adaniya S, Barta SK. · · 2021 · cited 250× · PMID 33661537 · DOI 10.1002/ajh.26151
Neurotoxicity and Cytokine Release Syndrome After Chimeric Antigen Receptor T Cell Therapy: Insights Into Mechanisms and Novel Therapies.
Siegler EL, Kenderian SS. · · 2020 · cited 204× · PMID 32983132 · DOI 10.3389/fimmu.2020.01973
Cytokines in CAR T Cell-Associated Neurotoxicity.
Gust J, Ponce R, Liles WC, Garden GA, et al · · 2020 · cited 191× · PMID 33391257 · DOI 10.3389/fimmu.2020.577027
GM-CSF: A Double-Edged Sword in Cancer Immunotherapy.
Kumar A, Taghi Khani A, Sanchez Ortiz A, Swaminathan S. · · 2022 · cited 188× · PMID 35865534 · DOI 10.3389/fimmu.2022.901277
Mechanisms of cytokine release syndrome and neurotoxicity of CAR T-cell therapy and associated prevention and management strategies.
Xiao X, Huang S, Chen S, Wang Y, et al · · 2021 · cited 187× · PMID 34794490 · DOI 10.1186/s13046-021-02148-6
Tissue macrophages: origin, heterogenity, biological functions, diseases and therapeutic targets.
Guan F, Wang R, Yi Z, Luo P, et al · · 2025 · cited 155× · PMID 40055311 · DOI 10.1038/s41392-025-02124-y
CAR-T Cell Therapy: the Efficacy and Toxicity Balance.
Chohan KL, Siegler EL, Kenderian SS. · · 2023 · cited 125× · PMID 36763238 · DOI 10.1007/s11899-023-00687-7
GM-CSF: A Promising Target in Inflammation and Autoimmunity.
Lee KMC, Achuthan AA, Hamilton JA. · · 2020 · cited 112× · PMID 33150139 · DOI 10.2147/itt.s262566

Verify or expand the search:

Other trials of Cyclophosphamide

Trials testing the same drug.

NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07509008 — Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Manageme · Phase 1, PHASE2 · not yet recruiting
NCT07444632 — Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/ · Phase 1 · not yet recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) · Phase 1 · not yet recruiting
NCT07437963 — Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatmen · Phase 1, PHASE2 · not yet recruiting

Other Kite, A Gilead Company trials

Trials by the same sponsor.

NCT05537766 — Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies · Phase 2 · terminated
NCT05459571 — Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma · Phase 2 · completed
NCT04789408 — Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia · Phase 1 · terminated
NCT04880434 — Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) · Phase 2 · completed
NCT04002401 — Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cel · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04314843 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kite, A Gilead Company
Last refreshed: 4 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04314843.

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