NCT03761056 (ZUMA-12) is a Phase 2 clinical trial of Axicabtagene Ciloleucel in B-cell Lymphoma, sponsored by Kite, A Gilead Company.

Who is sponsoring NCT03761056?

NCT03761056 is sponsored by Kite, A Gilead Company.

What drugs are being tested in NCT03761056?

Interventions in NCT03761056: Axicabtagene Ciloleucel, Fludarabine, Cyclophosphamide.

What condition does NCT03761056 study?

NCT03761056 studies B-cell Lymphoma.

Is NCT03761056 still recruiting?

NCT03761056 is currently completed. Last updated 4 December 2024.

Are results published for NCT03761056?

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

Last reviewed 2024-12-04 · How we verify

NCT03761056: ZUMA-12

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

Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma

Completed Phase 2 Results posted Last updated 4 December 2024

What this trial tests

Phase 2 trial testing Axicabtagene Ciloleucel in B-cell Lymphoma in 42 participants. Completed in 12 October 2023.

Timeline

29 January 2019

Primary endpoint
12 October 2023

12 October 2023

Quick facts

Lead sponsor	Kite, A Gilead Company
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	29 January 2019
Primary completion	12 October 2023
Estimated completion	12 October 2023
Sites	7 locations across France, United States, Australia

Drugs / interventions tested

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

Conditions studied

B-cell Lymphoma — all drugs for B-cell Lymphoma →

Sponsor

Kite, A Gilead Company — full company profile →

Who can join

18 and older, any sex, with 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.

Complete Response (CR) Rate Per the Lugano Classification as Determined by Study Investigators Primary · Up to 4 years

CR Rate is the percentage of participants with CR (complete metabolic response (CMR); complete radiological response (CRR)). CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion (LDi); no extralymphatic sites of disease; absent non-measured lesion (NMLs); organ enlar

Group	Value	95% CI
Axicabtagene Ciloleucel	86	71 – 95

Objective Response Rate (ORR) Per the Lugano Classification as Determined by Study Investigators Secondary · Up to 4 years

ORR: percentage of participants with CR (CMR;CRR) or PR (partial metabolic response (PMR); partial radiologic response (PRR)). CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤mediastinum), 3 (uptake \>mediastinum but ≤liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to ≤1.5 cm in LDi; no extralymphatic sites of disease; absent NMLs; organ enlargement regress to normal; no new sites; bone marrow morphology normal. PMR: scores 4 (uptake moderately \>liver),5 (uptake markedly \>liver, new lesions)

Group	Value	95% CI
Axicabtagene Ciloleucel	92	78 – 98

Duration of Response (DOR) Per the Lugano Classification Secondary · Up to 4 years

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 (PD) (Lugano classification) or death from any cause. Objective response is defined in outcome measure (OM) 2. PD is defined as a score 4 (uptake moderately \> liver) or 5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than a

Group	Value	95% CI
Axicabtagene Ciloleucel	NA	NA – NA

Event-Free Survival (EFS) Secondary · Up to 4 years

EFS was defined as the time from axicabtagene ciloleucel infusion date to earliest date of disease progression (Lugano classification), commencement of subsequent new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD is defined in OM 3. KM estimates were used for analysis.

Group	Value	95% CI
Axicabtagene Ciloleucel	NA	NA – NA

Progression-Free Survival (PFS) Secondary · Up to 4 years

PFS was defined as the time from axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 3. KM estimates were used for analysis.

Group	Value	95% CI
Axicabtagene Ciloleucel	NA	NA – NA

Overall Survival (OS) Secondary · Up to 4 years

OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause. KM estimates were used for analysis.

Group	Value	95% CI
Axicabtagene Ciloleucel	NA	NA – NA

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAE) Secondary · Up to 2 years

An AE was any untoward medical occurrence in a participant in a clinical trial participant, which did not necessarily have a causal relationship with the treatment. Treatment-emergent adverse events were defined as any adverse event with onset on or after the axicabtagene ciloleucel infusion. Serious adverse event was defined as an event that resulted in the following: death; life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; and medically important event or

TEAEs

Group	Value	95% CI
Axicabtagene Ciloleucel	100

Treatment-Emergent SAE

Group	Value	95% CI
Axicabtagene Ciloleucel	55

Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Secondary · Up to 2 years

Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Hemoglobin

Group	Value	95% CI
Axicabtagene Ciloleucel	3

Alanine Aminotransferase

Group	Value	95% CI
Axicabtagene Ciloleucel	8

Alkaline Aminotransferase

Group	Value	95% CI
Axicabtagene Ciloleucel	0

Aspartate Aminotransferase

Group	Value	95% CI
Axicabtagene Ciloleucel	5

Bilirubin

Group	Value	95% CI
Axicabtagene Ciloleucel	20

Calcium

Group	Value	95% CI
Axicabtagene Ciloleucel	5

Creatinine

Group	Value	95% CI
Axicabtagene Ciloleucel	5

Glucose

Group	Value	95% CI
Axicabtagene Ciloleucel	15

Percentage of Participants Experiencing Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Decreased Parameter Value Secondary · Up to 2 years

Grading categories were determined by CTCAE version 5.0.

Hemoglobin

Group	Value	95% CI
Axicabtagene Ciloleucel	43

Leukocytes

Group	Value	95% CI
Axicabtagene Ciloleucel	93

Lymphocytes

Group	Value	95% CI
Axicabtagene Ciloleucel	75

Neutrophils

Group	Value	95% CI
Axicabtagene Ciloleucel	95

Platelets

Group	Value	95% CI
Axicabtagene Ciloleucel	25

Albumin

Group	Value	95% CI
Axicabtagene Ciloleucel	3

Calcium

Group	Value	95% CI
Axicabtagene Ciloleucel	10

Glucose

Group	Value	95% CI
Axicabtagene Ciloleucel	0

Relapse With Central Nervous System (CNS) Disease Secondary · Up to 4 years

Relapse with CNS disease was defined as the time from the axicabtagene ciloleucel infusion date to the earliest date of CNS involvement with lymphoma as determined by typical symptoms, cerebrospinal fluid (CSF) evaluation, and/or diagnostic imaging.

Group	Value	95% CI
Axicabtagene Ciloleucel	0	0 – 0

Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood Secondary · Up to Month 24

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

Group	Value	95% CI
Axicabtagene Ciloleucel	36.27	20.51 – 133.96

Peak Serum Level of Granzyme B, Interferon-gamma (IFNg), Interleukin (IL)-2, IL-5, IL-6, IL-8 Secondary · Up to Week 4

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

Granzyme B

Group	Value	95% CI
Axicabtagene Ciloleucel	28.5	11.8 – 75.6

IFNg

Group	Value	95% CI
Axicabtagene Ciloleucel	409.4	157.8 – 856.8

IL-2

Group	Value	95% CI
Axicabtagene Ciloleucel	16.4	9.7 – 32.9

IL-5

Group	Value	95% CI
Axicabtagene Ciloleucel	6.3	6.3 – 26.2

IL-6

Group	Value	95% CI
Axicabtagene Ciloleucel	35.1	13.2 – 181.1

IL-8

Group	Value	95% CI
Axicabtagene Ciloleucel	63.0	30.1 – 107.5

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality: Up to 4 years; Adverse events: Up to 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Axicabtagene Ciloleucel

Serious: 22/40 (55%)

Deaths: 7/42

Retreatment Axicabtagene Ciloleucel

Serious: 1/1 (100%)

Deaths: 1/1

Serious adverse events (36 terms)

Reaction	System	Axicabtagene Ciloleucel	Retreatment Axicabtagene C…
Encephalopathy	Nervous system disorders	—	—
Confusional state	Psychiatric disorders	—	—
Pyrexia	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Covid-19	Infections and infestations	—	—
Covid-19 pneumonia	Infections and infestations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Pericardial effusion	Cardiac disorders	—	—
Sinus bradycardia	Cardiac disorders	—	—
Supraventricular tachycardia	Cardiac disorders	—	—
Hypothyroidism	Endocrine disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Autoimmune disorder	Immune system disorders	—	—
Cytomegalovirus infection reactivation	Infections and infestations	—	—
Device related infection	Infections and infestations	—	—
Periorbital infection	Infections and infestations	—	—
Skin infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Neutrophil count decreased	Investigations	—	—
Platelet count decreased	Investigations	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (59 terms — click to expand)

Reaction	System	Axicabtagene Ciloleucel	Retreatment Axicabtagene C…
Pyrexia	General disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Neutrophil count decreased	Investigations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
White blood cell count decreased	Investigations	—	—
Hypotension	Vascular disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Chills	General disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Confusional state	Psychiatric disorders	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Tremor	Nervous system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Encephalopathy	Nervous system disorders	—	—
Alanine aminotransferase increased	Investigations	—	—
Platelet count decreased	Investigations	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—
Insomnia	Psychiatric disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Oedema peripheral	General disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Hypogammaglobulinaemia	Immune system disorders	—	—
Lymphocyte count decreased	Investigations	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Agitation	Psychiatric disorders	—	—
Sinus bradycardia	Cardiac disorders	—	—
Ventricular arrhythmia	Cardiac disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Blood bilirubin increased	Investigations	—	—

Most-reported serious reactions: Encephalopathy, Confusional state, Pyrexia, Non-cardiac chest pain, Covid-19, Covid-19 pneumonia, Back pain, Anaemia.

Data from ClinicalTrials.gov NCT03761056 adverse events section.

Sponsor's own description

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma. After the end of KTE-C19-112 (ZUMA-12), participants who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.

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
Axicabtagene ciloleucel as first-line therapy in high-risk large B-cell lymphoma: the phase 2 ZUMA-12 trial.
Neelapu SS, Dickinson M, Munoz J, Ulrickson ML, et al · · 2022 · cited 219× · PMID 35314842 · DOI 10.1038/s41591-022-01731-4
Trial watch: chemotherapy-induced immunogenic cell death in immuno-oncology.
Vanmeerbeek I, Sprooten J, De Ruysscher D, Tejpar S, et al · · 2020 · cited 179× · PMID 32002302 · DOI 10.1080/2162402x.2019.1703449
Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials.
Westin JR, Kersten MJ, Salles G, Abramson JS, et al · · 2021 · cited 163× · PMID 34310745 · DOI 10.1002/ajh.26301
Fibroblast Activation Protein (FAP)-Targeted CAR-T Cells: Launching an Attack on Tumor Stroma.
Bughda R, Dimou P, D'Souza RR, Klampatsa A. · · 2021 · cited 135× · PMID 34386436 · DOI 10.2147/itt.s291767
Mechanisms of resistance to chimeric antigen receptor-T cells in haematological malignancies.
Ruella M, Korell F, Porazzi P, Maus MV. · · 2023 · cited 123× · PMID 37907724 · DOI 10.1038/s41573-023-00807-1
Next-Generation CAR T-cell Therapies.
Young RM, Engel NW, Uslu U, Wellhausen N, et al · · 2022 · cited 123× · PMID 35417527 · DOI 10.1158/2159-8290.cd-21-1683
New agents and regimens for diffuse large B cell lymphoma.
Wang L, Li LR, Young KH. · · 2020 · cited 109× · PMID 33317571 · DOI 10.1186/s13045-020-01011-z

Verify or expand the search:

Other trials of Axicabtagene Ciloleucel

Trials testing the same drug.

NCT07042438 — Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Expo · Phase 2 · recruiting
NCT06935136 — Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large · NA · not yet recruiting
NCT06912529 — Axicabtagene Ciloleucel CAR T-cells in Patients With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma · Phase 2 · terminated
NCT05077527 — Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma · Phase 1 · recruiting
NCT06826118 — Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma · Phase 2 · recruiting

Other recruiting trials for B-cell Lymphoma

Currently open trials in the same condition.

NCT07211048 — Anti CD19 Gene Therapy for B-cell Lymphoma · NA · recruiting
NCT06758713 — Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies · Phase 1 · recruiting
NCT06820268 — A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies · Phase 1 · recruiting
NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
NCT06744075 — Study of the Clearance of Minimal Residual Disease Measured at the End of First-line Treatment in Patients With Lymphoma · NA · active not 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
NCT04314843 — Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma · Phase 1 · terminated

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 NCT03761056 (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 December 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/NCT03761056.

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