Relapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaPhase 1/2ZUMA-4NCT02625480
Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
A Phase 1/2 study testing Brexucabtagene Autoleucel (KTE-X19), Fludarabine and Cyclophosphamide in people with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia and Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma, run by Kite, A Gilead Company at 30 sites in 11 countries.
Trial summary
The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL). Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Brexucabtagene Autoleucel (KTE-X19), Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 30 sitesin 11 countries
- Study dates
- 1 Feb 2016to 25 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Relapsed or refractory B-precursor ALL defined as one of the following:
- Primary refractory disease
- Any relapse within 18 months after first diagnosis
- Relapsed or refractory disease after 2 or more lines of systemic therapy
- Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from stem cell transplant at the time of enrollment
- Disease burden defined as at least 1 of the following:
Show all 35Show fewer
- Morphological disease in the bone marrow (> 5% blasts)
- Minimal/Measurable Residual Disease (MRD) positive (threshold 10^-4 by flow or Polymerase chain reaction (PCR))
- Individuals with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
- Age ≤ 21 years and weight ≥ 6 kg at the time of assent or consent per Institutional Review Board (IRB) guidelines
- Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at the time of assent/consent) performance status ≥ 80 at screening
- Adequate renal, hepatic, pulmonary and cardiac function defined as:
- Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) ≥ 60 mL/min
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN, except in individuals with Gilbert's syndrome
- Left ventricular shortening fraction (LVSF) ≥ 30% or left ventricular ejection fraction (LVEF) ≥ 50%, as determined by an echocardiogram or multi-gated acquisition scan (MUGA), no evidence of pericardial effusion (except trace or physiological) as determined by an echocardiogram (ECHO) and no clinically significant arrhythmias
- No clinically significant pleural effusion, pericardial effusion or ascites
- Baseline oxygen saturation > 92% on room air
- Histologically confirmed aggressive B cell NHL
- Relapsed or refractory histologically confirmed aggressive B-cell NHL per 1 or more of the following:
- Primary refractory disease
- Any relapse within 18 months after first diagnosis
- Relapsed or refractory disease after 1 or more lines of systemic therapy
- Relapsed or refractory disease after autologous /allogeneic stem cell transplant provided individual is at least 6 weeks from autologous stem cell transplant and at least 3 months from allogeneic stem cell transplant at the time of enrollment
- Individuals must have received adequate prior therapy including at a minimum all of the following:
- Anti-CD20 monoclonal antibody, unless the investigator determines that the tumor is CD20 negative
- An anthracycline-containing chemotherapy regimen
- Age <18 years old and weight ≥ 6kg
- Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at the time of assent/consent) performance status ≥ 80 at screening
- Adequate renal, hepatic, pulmonary, and cardiac function defined as the following:
- Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) ≥ 60 mL/min
- Serum ALT/AST ≤ 5 ULN
- Total bilirubin ≤1.5 x ULN except in individuals with Gilbert's syndrome
- Left ventricular shortening fraction(LVSF) ≥ 30% or left ventricular ejection fraction (LVEF) ≥ 50%, as determined by ECHO or MUGA, no evidence of pericardial effusion (except trace or physiological) as determined by an ECHO, and no clinically significant arrhythmias
- Baseline oxygen saturation > 92% on room air
Who cannot join
- Diagnosis of Burkitt's leukemia/lymphoma according to the World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
- History of severe hypersensitivity reaction to aminoglycosides or any of the agents used in this study
- Central nervous system (CNS) involvement and abnormalities:
- Any CNS tumor mass by imaging and/or parameningeal mass (cranial and/or spinal)
- Presence of central nervous system (CNS)-3 disease, defined as white blood cell (WBC) ≥ 5/µL in Cerebrospinal Fluid (CSF) with presence of lymphoblasts with or without neurologic symptoms
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- CNS-2 disease, defined as WBC < 5/µL in CSF with presence of lymphoblasts and with neurologic symptoms (see note below for further clarification).
- Note: Neurologic symptoms may include but are not limited to cranial nerve palsy (if not explained by extracranial tumor) and clinical cord compression.
- (Individuals with CNS-1 (no detectable lymphoblasts in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study)
- History or presence of CNS disorder, such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema with confirmed structural defects not related to lymphoma by appropriate imaging. History of stroke or transient ischemic attack within 12 months before enrollment. Individuals with seizure disorders requiring active anticonvulsive medication.
- History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.
- Primary immunodeficiency
- History of human immunodeficiency virus (HIV) infection or acute / chronic active hepatitis B or C infection. Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines.
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
- Prior medication:
- Prior CD19 directed therapy (other than blinatumomab), including CAR+ T cell, bispecific T cell engager (BiTE), and antibody drug conjugate (ADC), with the exception of individuals who received brexucabtagene autoleucel (KTE-X19) in this study and are eligible for re-treatment
- Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
- Donor lymphocyte infusion (DLI) within 28 days prior to enrollment
- Any drug used for graft-versus-host disease (GVHD) within 4 weeks prior to enrollment
- Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment
- Live vaccine ≤ 6 weeks prior to enrollment
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization are not considered to be of childbearing potential
- Individuals of both genders of child-bearing potential who are not willing to use a birth control method considered to be highly effective per protocol from the time of consent through 6 months after conditioning chemotherapy or brexucabtagene autoleucel (KTE-X19) infusion, whichever is longer.
- History of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, breast), or follicular lymphoma (FL) unless disease free for at least 3 years
- Autologous stem cell transplant within <6 weeks of planned KTE-X19 infusion; allogeneic stem cell transplant within <3 months of planned KTE-X19 infusion
- Prior CD19 targeted therapy other than blinatumomab and loncastuximab tesirine-lpyl
- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
- History of HIV infection or acute/chronic active hepatitis B or C infection. Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines
- Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by International Bone Marrow Transplant Registry (IBMTR) index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment.
- CNS involvement and abnormalities:
- Any CNS tumor mass and/or parameningeal mass (cranial and/or spinal) by imaging with current or prior history of neurological symptoms within 3 months prior to screening.
- Note: CNS involvement without neurologic symptoms will be allowed.
- History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema with confirmed structural defects by appropriate imaging. History of stroke or transient ischemic attack within 12 months before enrollment. Individuals with seizure disorders requiring active anti-convulsive medication.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
- Primary immunodeficiency
- History of severe immediate hypersensitivity reaction to any of the agents used in this study
- Live vaccine ≤ 6 weeks prior to planned start of lymphodepleting chemotherapy regimen
- Individuals of both genders of child-bearing potential who are not willing to use a birth control considered to be highly effective per protocol from the time of consent through 12 months after the completion of lymphodepleting chemotherapy or brexucabtagene autoleucel (KTE-X19) infusion, whichever is longer.
- Prior medication:
- Prior CD19 directed therapy (other than blinatumomab), including CAR+ T cell, BiTE, and ADC, with the exception of individuals who received brexucabtagene autoleucel (KTE-X19) in this study and are eligible for re-treatment
- Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
- DLI within 28 days prior to enrollment
- Any drug used for GVHD within 4 weeks prior to enrollment
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
30 sites in 11 countries.
30 sites in 11 countries
United States15 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Virginia Health System, Pediatric Hematology/Oncology Clinic
Charlottesville, Virginia, 22908
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Texas Children's Hospital
Houston, Texas, 77030
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Miami Hospital & Clinics
Miami, Florida, 33136
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
Monroe-Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP
New York, New York, 10032
Children's Hospital of Orange County
Orange, California, 92868
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Rochester Medical Center
Rochester, New York, 14642
UCSF Benioff Children's Hospital
San Francisco, California, 94158
France4 sites
Unité d'Oncologie et Hématologie Pédiatriques
Bordeaux, 33 000
Institut d'Hematologie et Oncologie Pediatrique
Lyon, 69373
Hopital d'Enfants la Timone
Marseille, 13385
Hopital Robert Debre - Sevice d'Hemato-immunologic
Paris, 75935
Poland2 sites
Jurasz University Hospital 1; Collegium Medicum
Bydgoszcz, 85-094
Wroclaw Medical University
Wroclaw, 50-556
Spain2 sites
Hospital Sant Joan de Déu
Barcelona, 08950
Hospital Universitario La Paz
Madrid, 28046
Germany1 site
University Medical Center Hamburg-Eppendorf (UKE)
Hamburg, 20246
About this study
Official title: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)
The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).
As of October 2022, no further patients with acute B-cell Acute Lymphoblastic Leukemia (ALL) will be asked to join the study. The study remains open for recruitment for patients that have B-cell Non Hodgkin Lymphoma (NHL).
Read the detailed description
All participants who received KTE-X19, and have completed at least 24 months of protocol assessments, will be transitioned to a separate long-term follow-up (LTFU) study. The purpose of the LTFU study (KT-US-982-5968.) is to complete the remainder of the 15-year follow-up assessments.
- Conditions
- Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
- Being tested
- Brexucabtagene Autoleucel (KTE-X19), Fludarabine, Cyclophosphamide
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brexucabtagene Autoleucel (KTE-X19)Biological
FludarabineDrug
Administered intravenously
CyclophosphamideDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR+ T cells/kg or 1 x 10^6 anti-CD19 CAR+ T cells/kg. Receives: Biological: Brexucabtagene Autoleucel (KTE-X19); Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT)
Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel (KTE-X19)-related events with onset within the first 28 days following brexucabtagene autoleucel (KTE-X19) infusion.
Measured: Up to 28 days
Phase 2: Overall Complete Remission Rate in the ALL Cohort
Overall complete remission rate will be determined per independent review.
Measured: Up to 24 months
Phase 2: Objective Response Rate in the NHL Cohorts
Objective Response Rate will be determined per investigator review.
Measured: Up to 24 months
Secondary outcomes (11)
Minimum Residual Disease Negative Remission Rate in the ALL Cohort
Minimal residual disease (MRD) response rate is defined as MRD < 10^-4 per the standard assessment.
Measured: Up to 3 months
Allogeneic Stem Cell Transplant Rate in the ALL Cohort
The incidence of allogeneic stem cell transplant will be analyzed.
Measured: Up to 24 months
Changes Over Time in Patient Reported Outcomes (PRO) Scores in the ALL and NHL Cohorts
The PRO scores will be measured by the Pediatric Quality of Life Inventory (PedsQL) for children and adolescents and European Quality-of-Life-5 Dimension (EQ-5D) for all participants.
The PedsQL comprises of 23 items in the dimensions of physical, emotional, social, and school functioning. Transformed total, physical health summary, and psychosocial health summary scores range from 0-100 with higher scores indicating better health-related quality of life.
The EQ-5D is a generic questionnaire for assessing the participant's overall health status. The EQ-5D consists of a 5 dimension descriptive system including mobility, self-care, usual activities, pain/comfort, and anxiety/depression and a visual analogue scale (EQ-VAS) which allows the respondent to record health. The VAS allows a participant to indicate self-reported health on a vertical scale, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The PedsQL scores and EQ-5D scores will be reported.
Measured: Up to 10 years
Overall Complete Remission Rate in the ALL Cohort
Measured: Up to 10 years
Relapse-Free Survival for the ALL Cohort
Relapse-Free Survival is defined as the time from the brexucabtagene autoleucel (KTE-X19) infusion date to the date of disease relapse or death from any cause.
Measured: Up to 24 months
Progression Free Survival in the NHL Cohort
Measured: Up to 10 years
Overall Survival in the ALL and NHL Cohorts
Overall survival is defined as the time from brexucabtagene autoleucel (KTE-X19) infusion to the date of death from any cause.
Measured: Up to 10 years
Duration of Remission in the ALL and NHL Cohorts
Duration of remission is defined as the time between the participant's first complete response per independent review to relapse or any death in the absence of documented relapse.
Measured: Up to 24 months
Percentage of Participants with Anti-Brexucabtagene Autoleucel (KTE-X19) Antibodies in Blood in the ALL and NHL Cohorts
Measured: Up to 10 years
Percentage of Participants Experiencing Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values in ALL and NHL Cohorts
Measured: Up to 10 years
CR Rate Within 3 Months Per Independent Review in ALL Cohorts
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start1 Feb 2016
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625480
- Sponsor's protocol ID
- KTE-C19-104
- Other IDs
- 2023-509440-97, 2023
- Acronym
- ZUMA-4
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2015
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
Publications
Wayne AS, Huynh V, Hijiya N, Rouce RH, Brown PA, Krueger J, Kitko CL, Ziga ED, Hermiston ML, Richards MK, Baruchel A, Schuberth PC, Rossi J, Zhou L, Goyal L, Jain R, Vezan R, Masouleh BK, Lee DW. Three-year results from phase I of ZUMA-4: KTE-X19 in pediatric relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2023 Mar 1;108(3):747-760. doi: 10.3324/haematol.2022.280678.
PubMed 36263840
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)
- ClinicalTrials.gov ID
- NCT02625480
- Acronym / sponsor ID
- ZUMA-4 / KTE-C19-104
- Conditions
- Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).
As of October 2022, no further patients with acute B-cell Acute Lymphoblastic Leukemia (ALL) will be asked to join the study. The study remains open for recruitment for patients that have B-cell Non Hodgkin Lymphoma (NHL).
Detailed description
All participants who received KTE-X19, and have completed at least 24 months of protocol assessments, will be transitioned to a separate long-term follow-up (LTFU) study. The purpose of the LTFU study (KT-US-982-5968.) is to complete the remainder of the 15-year follow-up assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Biological: Brexucabtagene Autoleucel (KTE-X19), Drug: Fludarabine, Drug: CyclophosphamideA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR+ T cells/kg or 1 x 10^6 anti-CD19 CAR+ T cells/kg. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (35 listed)
- Relapsed or refractory B-precursor ALL defined as one of the following:
- Disease burden defined as at least 1 of the following:
- Individuals with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
- Age ≤ 21 years and weight ≥ 6 kg at the time of assent or consent per Institutional Review Board (IRB) guidelines
- Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at the time of assent/consent) performance status ≥ 80 at screening
Key exclusion criteria (47 listed)
- Diagnosis of Burkitt's leukemia/lymphoma according to the World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
- History of severe hypersensitivity reaction to aminoglycosides or any of the agents used in this study
- Central nervous system (CNS) involvement and abnormalities:
- History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brexucabtagene Autoleucel (KTE-X19) | Biological | Single Arm |
| FludarabineAdministered intravenously | Drug | Single Arm |
| CyclophosphamideAdministered intravenously | Drug | Single Arm |
Primary outcome
Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT)
Time frame: Up to 28 days
Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel (KTE-X19)-related events with onset within the first 28 days following brexucabtagene autoleucel (KTE-X19) infusion.
Phase 2: Overall Complete Remission Rate in the ALL Cohort
Time frame: Up to 24 months
Overall complete remission rate will be determined per independent review.
Phase 2: Objective Response Rate in the NHL Cohorts
Time frame: Up to 24 months
Objective Response Rate will be determined per investigator review.
11 secondary outcomes
Minimum Residual Disease Negative Remission Rate in the ALL Cohort
Time frame: Up to 3 months
Allogeneic Stem Cell Transplant Rate in the ALL Cohort
Time frame: Up to 24 months
Changes Over Time in Patient Reported Outcomes (PRO) Scores in the ALL and NHL Cohorts
Time frame: Up to 10 years
Overall Complete Remission Rate in the ALL Cohort
Time frame: Up to 10 years
Relapse-Free Survival for the ALL Cohort
Time frame: Up to 24 months
Progression Free Survival in the NHL Cohort
Time frame: Up to 10 years
Overall Survival in the ALL and NHL Cohorts
Time frame: Up to 10 years
Duration of Remission in the ALL and NHL Cohorts
Time frame: Up to 24 months
Percentage of Participants with Anti-Brexucabtagene Autoleucel (KTE-X19) Antibodies in Blood in the ALL and NHL Cohorts
Time frame: Up to 10 years
Percentage of Participants Experiencing Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) Grade Changes in Safety Laboratory Values in ALL and NHL Cohorts
Time frame: Up to 10 years
CR Rate Within 3 Months Per Independent Review in ALL Cohorts
Time frame: Up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Derived from this study: PubMed 36263840Wayne AS, Huynh V, Hijiya N, Rouce RH, Brown PA, Krueger J, Kitko CL, Ziga ED, Hermiston ML, Richards MK, Baruchel A, Schuberth PC, Rossi J, Zhou L, Goyal L, Jain R, Vezan R, Masouleh BK, Lee DW. Three-year results from phase I of ZUMA-4: KTE-X19 in pediatric relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2023 Mar 1;108(3):747-760. doi: 10.3324/haematol.2022.280678.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kite Study Director study director
Kite, A Gilead Company
30 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Brexucabtagene Autoleucel (KTE-X19), Fludarabine and Cyclophosphamide in people with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia and Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma, run by Kite, A Gilead Company at 30 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, France, Poland, Spain, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLT) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.