CClinicalTrials.gg
Sign In
TerminatedNCT04314843ZUMA-19Updated Mar 4, 2024Results posted

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

A Phase 1 interventional study of Cyclophosphamide and Fludarabine in Relapsed/Refractory Large B-cell Lymphoma, sponsored by Kite, A Gilead Company. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-04.

Sponsored by Kite, A Gilead Company · Phase 1, Interventional, and Treatment

Why this study was terminated
Development program terminated and the decision was not due to any safety concerns.
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This study was intended to be a Phase 1/2, but the planned Phase 2 part has been canceled.

All participants who received an infusion of lenzilumab and axicabtagene ciloleucel will be provided the opportunity to transition to a separate long-term follow-up (LTFU) study, KT-US-982-5968.

02

Conditions studied

  • Relapsed/Refractory Large B-cell Lymphoma

Keywords

  • Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF)
  • GM-CSF antibody
  • Chimeric Antigen Receptor (CAR)
  • CD19
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 6 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Kite, A Gilead Company is the lead sponsor of 36 studies on the registry; 7 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Individuals with large B-cell lymphoma, including Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, Primary mediastinal large B-cell lymphoma (PMBCL), High-grade B-cell lymphoma (HGBL), and DLBCL arising from Follicular lymphoma (FL)

  • Individuals must have relapsed disease after 2 or more lines of systemic therapy, or chemorefractory disease defined as the following:

    • No response to first-line therapy, including the following:

      • Progressive disease (PD) as best response to first therapy
      • Stable disease (SD) as best response after ≥ 4 cycles of first-line therapy (eg, 4 cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP)), with SD duration no longer than 6 months from the last dose of therapy

    • No response to ≥ 2 lines of therapy, including the following:

      • PD as best response to most recent therapy
      • SD as best response after ≥ 2 cycles of last line of therapy

  • Individuals must have received adequate prior therapy including at a minimum:

    • Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and
    • An anthracycline-containing chemotherapy regimen
  • At least 1 measurable lesion according to the International Working Group Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
  • Magnetic resonance imaging of the brain showing no evidence of central nervous system (CNS) lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Individuals with a known medical history of tuberculosis or a risk for tuberculosis exposure require negative tuberculosis testing by either tuberculin skin test or interferon gamma release assay.

  • Adequate bone marrow function as evidenced by:

    • Absolute neutrophil count ≥ 1000/μL
    • Platelets ≥ 75,000/μL
    • Absolute lymphocyte count ≥ 100/μL

  • Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:

    • Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min
    • Serum alanine aminotransferase or aspartate aminotransferase ≤ 2.5 upper limit of normal
    • Total bilirubin ≤ 1.5 mg/dL, except in individuals with Gilbert's Syndrome
    • Cardiac ejection fraction ≥ 50% with no evidence of clinically significant pericardial effusion as determined by echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
    • No clinically significant pleural effusion
    • Baseline oxygen saturation > 92% on room air

Key Exclusion Criteria:

  • History of Richter's transformation of chronic lymphocytic leukemia
  • Autologous stem cell transplant (SCT) within 6 weeks of planned axicabtagene ciloleucel infusion
  • History of allogeneic stem cell transplantation
  • Prior CD19 targeted therapy or prior CAR T cell therapy
  • History of pulmonary alveolar proteinosis (PAP)
  • History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive) or hepatitis C (HCV) (anti-HCV positive) infection. A history of hepatitis B or hepatitis C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
  • Individuals with detectable Cerebrospinal fluid (CSF) malignant cells, or brain metastases, or with a history of CNS lymphoma, CSF malignant cells or brain metastases
  • History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Lenzilumab and Axicabtagene Ciloleucel

    Phase 1: Participants will receive cyclophosphamide and fludarabine lymphodepleting chemotherapy followed by sequenced therapy of lenzilumab and axicabtagene ciloleucel on Day 0 to determine a recommended Phase 2 dose (RP2D) of lenzilumab. Phase 2: Participants will receive cyclophosphamide and fludarabine lymphodepleting chemotherapy followed by sequenced therapy of lenzilumab, at the RP2D, and axicabtagene ciloleucel on Day 0.

    Drug: Cyclophosphamide · Drug: Fludarabine · Biological: Lenzilumab · Biological: Axicabtagene Ciloleucel

Interventions

  • DrugCyclophosphamide

    Administered according to package insert

  • DrugFludarabine

    Administered according to package insert

  • BiologicalLenzilumab

    Administered as an IV infusion

    Also known as: Humaneered® anti-human GM-CSF monoclonal antibody

  • BiologicalAxicabtagene Ciloleucel

    A single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously.

    Also known as: Yescarta®

06

What researchers measure

Primary outcomes

  1. Phase 1: Percentage of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy With Lenzilumab and Axicabtagene

    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

    Time frame: First infusion of lenzilumab and axicabtagene ciloleucel up to 28 days.

  2. Phase 2: Percentage of Participants Experiencing Grade 2 or Higher Neurologic Events Within 28 Days of Axicabtagene Ciloleucel Administration

    Time frame: Up to 28 days

Secondary outcomes

  1. Phase 1 and Phase 2: Percentage of Participants Experiencing Adverse Events

    Time frame: Enrollment through 3 months after lenzilumab and axicabtagene ciloleucel infusion.

  2. Phase 1 and Phase 2: Percentage of Participants Experiencing Serious Adverse Events

    Time frame: Enrollment through 3 months after lenzilumab and axicabtagene ciloleucel infusion.

  3. Phase 1 and Phase 2: Percentage of Participants Experiencing Cytokine Release Syndrome

    Time frame: Enrollment through 12 months after lenzilumab and axicabtagene ciloleucel infusion or until disease progression, whichever occurred first.

  4. Phase 1 and Phase 2: Percentage of Participants Experiencing Neurologic Events

    Time frame: Enrollment through 12 months after lenzilumab and axicabtagene ciloleucel infusion or until disease progression, whichever occurred first.

  5. Phase 1 and Phase 2: Complete Response (CR) Rate Per Internal Working Group (IWG) Lugano Classification as Determined by the Study Investigators

    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.

    Time frame: First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

  6. Phase 1 and Phase 2: Objective Response Rate (ORR) Per IWG Lugano Classification as Determined by Study Investigators

    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 and residual masses of any size;no new sites;residual update \> update in normal bone marrow but reduced compared with baseline.PRR:≥ 50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites;absent/normal, regressed, but no increase of nonmeasured lesions;spleen regressed by \> 50% in length beyond normal;no new sites.

    Time frame: First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

  7. 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

    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.

    Time frame: First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

  8. Phase 1 and Phase 2: Progression-Free Survival (PFS) Per IWG Lugano Classification as Determined by Study Investigators

    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.

    Time frame: First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

  9. Phase 1 and Phase 2: Overall Survival (OS)

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

    Time frame: First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).

  10. 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

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

    Time frame: Baseline up to Week 4

  11. Phase 1 and Phase 2: Axicabtagene Ciloleucel Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood

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

    Time frame: Baseline up to Month 3

07

Results

Posted Mar 4, 2024

Participant flow

Participants were enrolled at study sites in the United States.

Participant flow — Overall Study
MilestonePhase 1/Cohort 1Phase 1/Cohort 2
Started33
Completed00
Not completed33
Withdrew: Death22
Withdrew: Rolled over to long-term follow-up study after study terminated11

Outcome measures

PrimaryPhase 1: Percentage of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy With Lenzilumab and Axicabtagene

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

Time frame:
First infusion of lenzilumab and axicabtagene ciloleucel up to 28 days.
Reported as:
Number · percentage of participants
Phase 1: Percentage of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy With Lenzilumab and Axicabtagene
percentage of participantsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1: Percentage of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) Related to Sequenced Therapy With Lenzilumab and Axicabtagene00
PrimaryPhase 2: Percentage of Participants Experiencing Grade 2 or Higher Neurologic Events Within 28 Days of Axicabtagene Ciloleucel Administration
Time frame:
Up to 28 days

No measurements were reported for this outcome.

SecondaryPhase 1 and Phase 2: Percentage of Participants Experiencing Adverse Events
Time frame:
Enrollment through 3 months after lenzilumab and axicabtagene ciloleucel infusion.
Reported as:
Number · percentage of participants
Phase 1 and Phase 2: Percentage of Participants Experiencing Adverse Events
percentage of participantsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Percentage of Participants Experiencing Adverse Events100100
SecondaryPhase 1 and Phase 2: Percentage of Participants Experiencing Serious Adverse Events
Time frame:
Enrollment through 3 months after lenzilumab and axicabtagene ciloleucel infusion.
Reported as:
Number · percentage of participants
Phase 1 and Phase 2: Percentage of Participants Experiencing Serious Adverse Events
percentage of participantsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Percentage of Participants Experiencing Serious Adverse Events67100
SecondaryPhase 1 and Phase 2: Percentage of Participants Experiencing Cytokine Release Syndrome
Time frame:
Enrollment through 12 months after lenzilumab and axicabtagene ciloleucel infusion or until disease progression, whichever occurred first.
Reported as:
Number · percentage of participants
Phase 1 and Phase 2: Percentage of Participants Experiencing Cytokine Release Syndrome
percentage of participantsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Percentage of Participants Experiencing Cytokine Release Syndrome6767
SecondaryPhase 1 and Phase 2: Percentage of Participants Experiencing Neurologic Events
Time frame:
Enrollment through 12 months after lenzilumab and axicabtagene ciloleucel infusion or until disease progression, whichever occurred first.
Reported as:
Number · percentage of participants
Phase 1 and Phase 2: Percentage of Participants Experiencing Neurologic Events
percentage of participantsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Percentage of Participants Experiencing Neurologic Events10067
SecondaryPhase 1 and Phase 2: Complete Response (CR) Rate Per Internal Working Group (IWG) Lugano Classification as Determined by the Study Investigators

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.

Time frame:
First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).
Reported as:
Number · percentage of participants
Phase 1 and Phase 2: Complete Response (CR) Rate Per Internal Working Group (IWG) Lugano Classification as Determined by the Study Investigators
percentage of participantsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Complete Response (CR) Rate Per Internal Working Group (IWG) Lugano Classification as Determined by the Study Investigators67 (9 to 99)67 (9 to 99)
SecondaryPhase 1 and Phase 2: Objective Response Rate (ORR) Per IWG Lugano Classification as Determined by Study Investigators

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 and residual masses of any size;no new sites;residual update \> update in normal bone marrow but reduced compared with baseline.PRR:≥ 50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites;absent/normal, regressed, but no increase of nonmeasured lesions;spleen regressed by \> 50% in length beyond normal;no new sites.

Time frame:
First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).
Reported as:
Number · percentage of participants
Phase 1 and Phase 2: Objective Response Rate (ORR) Per IWG Lugano Classification as Determined by Study Investigators
percentage of participantsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Objective Response Rate (ORR) Per IWG Lugano Classification as Determined by Study Investigators67 (9 to 99)100 (29 to 100)
SecondaryPhase 1 and Phase 2: Duration of Response (DOR) in Participants Who Experience an Objective Response Per IWG Lugano Classification as Determined by Study Investigators

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.

Time frame:
First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).
Reported as:
Median · Months
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
MonthsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Duration of Response (DOR) in Participants Who Experience an Objective Response Per IWG Lugano Classification as Determined by Study Investigators9.9 (NA to NA)12.1 (2.7 to NA)
SecondaryPhase 1 and Phase 2: Progression-Free Survival (PFS) Per IWG Lugano Classification as Determined by Study Investigators

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.

Time frame:
First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).
Reported as:
Median · Months
Phase 1 and Phase 2: Progression-Free Survival (PFS) Per IWG Lugano Classification as Determined by Study Investigators
MonthsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Progression-Free Survival (PFS) Per IWG Lugano Classification as Determined by Study Investigators10.8 (0.9 to NA)13.0 (3.6 to NA)
SecondaryPhase 1 and Phase 2: Overall Survival (OS)

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

Time frame:
First infusion date axicabtagene ciloleucel to data cut off date of 09 May 2022 (maximum duration: 22.3 months).
Reported as:
Median · Months
Phase 1 and Phase 2: Overall Survival (OS)
MonthsPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Overall Survival (OS)10.8 (4.6 to NA)13.0 (3.6 to NA)
SecondaryPhase 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

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

Time frame:
Baseline up to Week 4
Reported as:
Median · pg/mL
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
pg/mLPhase 1/Cohort 1Phase 1/Cohort 2
CXCL102000.00 (1474.50 to 2000.00)809.40 (448.60 to 1298.10)
Granzyme B14.50 (9.20 to 44.20)11.80 (2.60 to 17.80)
IFN-gamma1238.30 (90.60 to 1426.00)45.70 (7.50 to 151.50)
IL-1 RA4984.00 (4038.00 to 6187.00)919.00 (701.00 to 1099.00)
IL-211.80 (6.30 to 22.70)18.20 (2.50 to 21.10)
IL-622.50 (8.00 to 976.00)13.10 (3.00 to 15.40)
IL-856.70 (12.90 to 75.70)31.50 (15.40 to 39.90)
TNF alpha5.50 (3.40 to 16.50)3.00 (1.70 to 3.30)
GM-CSF1.90 (1.90 to 1.90)1.90 (1.90 to 1.90)
MCP-11178.10 (1007.00 to 1300.00)866.80 (589.90 to 968.90)
SecondaryPhase 1 and Phase 2: Axicabtagene Ciloleucel Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood

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

Time frame:
Baseline up to Month 3
Reported as:
Mean · cells/μL
Phase 1 and Phase 2: Axicabtagene Ciloleucel Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood
cells/μLPhase 1/Cohort 1Phase 1/Cohort 2
Phase 1 and Phase 2: Axicabtagene Ciloleucel Pharmacokinetics: Peak Level of Anti-CD19 CAR T Cells in Blood74.28 ± 97.6020.35 ± 15.12

Adverse events

Collected over Adverse Events: Enrollment through 3 months after lenzilumab and axicabtagene ciloleucel infusion. All-Cause Mortality: Enrollment up to 22.5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 1/Cohort 12/3 (66.7%)2/3 (66.7%)3/3 (100%)
Phase 1/Cohort 22/3 (66.7%)3/3 (100%)3/3 (100%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventPhase 1/Cohort 1Phase 1/Cohort 2
EncephalopathyNervous system disorders1/32/3
AnaemiaBlood and lymphatic system disorders1/30/3
PyrexiaGeneral disorders0/31/3
Covid-19Infections and infestations0/31/3
Covid-19 pneumoniaInfections and infestations1/31/3
PneumoniaInfections and infestations0/31/3
Platelet count decreasedInvestigations1/30/3
HyponatraemiaMetabolism and nutrition disorders1/30/3
Muscular weaknessMusculoskeletal and connective tissue disorders0/31/3
AphasiaNervous system disorders0/31/3
Most frequent other events
Showing 10 of 61
Most frequent other events
EventPhase 1/Cohort 1Phase 1/Cohort 2
NeutropeniaBlood and lymphatic system disorders3/31/3
Neutrophil count decreasedInvestigations3/32/3
Muscular weaknessMusculoskeletal and connective tissue disorders0/33/3
LymphadenopathyBlood and lymphatic system disorders0/32/3
Sinus tachycardiaCardiac disorders0/32/3
ConstipationGastrointestinal disorders0/32/3
NauseaGastrointestinal disorders2/31/3
FatigueGeneral disorders2/31/3
MalaiseGeneral disorders0/32/3
PyrexiaGeneral disorders2/32/3

Baseline characteristics

The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel and/or any dose of lenzilumab.

Age, Categorical
Age, Categorical(Participants)Phase 1/Cohort 1Phase 1/Cohort 2Total
<=18 years000
Between 18 and 65 years224
>=65 years112
Age, Continuous
Age, Continuous(years)Phase 1/Cohort 1Phase 1/Cohort 2Total
Mean62 ± 15.765 ± 10.264 ± 12.0
Sex: Female, Male
Sex: Female, Male(Participants)Phase 1/Cohort 1Phase 1/Cohort 2Total
Female000
Male336
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase 1/Cohort 1Phase 1/Cohort 2Total
Hispanic or Latino000
Not Hispanic or Latino336
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase 1/Cohort 1Phase 1/Cohort 2Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White336
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Phase 1/Cohort 1Phase 1/Cohort 2Total
United States336
08

Study locations

10 sites
  • Stanford University
    Palo Alto, California 94305, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Northwestern University
    Evanston, Illinois 60208, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Columbia University Medical Center, New York-Presbyterian Hospital
    New York, New York 10032, United States
  • Levine Cancer Center
    Charlotte, North Carolina 28204, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • Vanderbilt University
    Nashville, Tennessee 37232, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Publications

  • Kenderian, S. S., Oluwole, O. O., Mccarthy, P. L., Reshef, R., Shiraz, P., Ahmed, O., Le Gall, J., Nahas, M., Tang, L. And Neelapu, S. S. Zuma-19: A Phase 1/2 Multicenter Study of Lenzilumab Use With Axicabtagene Ciloleucel (Axi-Cel) In Patients (Pts) With Relapsed Or Refractory Large B Cell Lymphoma (R/R Lbcl). Blood 136(Supplement 1): 6-7, (2020). Conference Proceedings.
  • Olalekan O. Oluwole, MBBS, Saad S. Kenderian, MD, Parveen Shiraz, MD, Reem Karmali, MD, MSc, Ran Reshef, MD, MSc, Philip L. McCarthy, MD, Nilanjan Ghosh, MD, PhD, Aleksandr Lazaryan, MD, PhD, MPH, Simone Filosto, PhD, Soumya Poddar, PhD, Daqin Mao, PhD, Andrew Peng, MS, Adrian Kilcoyne, MD, MPH, Myrna Nahas, MD, Sattva S. Neelapu, MD. A Phase 1/2 Study of Axicabtagene Ciloleucel Plus Lenzilumab in Patients With Relapsed or Refractory Large B-Cell Lymphoma. American Society of Hemotology; Dec 10-13, 2022; New Orleans, LA. Abstract 4635

Study documents

  • Study protocol · Aug 3, 2021
  • Statistical analysis plan · Jun 12, 2020
  • Statistical analysis plan · May 26, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04314843
Lead sponsor
Kite, A Gilead Company
Collaborators
Humanigen, Inc.
Responsible party
Sponsor
First posted
Mar 19, 2020
Start date
May 26, 2020
Primary completion
Mar 16, 2021
Completion
Jul 27, 2022
Results posted
Mar 4, 2024
Last update
Mar 4, 2024

Study contacts

Kite Study Director
study director · Kite, A Gilead Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma→

Other studies from this sponsor

Kite, A Gilead Company

Start the discussion