Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25)

A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25)

Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A), r/r Richter transformation (RT) (Substudy B), r/r Burkitt lymphoma (BL) (Substudy C) and r/r hairy cell leukemia (HCL) (Substudy D).

Study Overview

• Status: Terminated
• Conditions: Relapsed/Refractory Waldenstrom Macroglobulinemia; Relapsed/Refractory Richter Transformation; Relapsed/Refractory Burkitt Lymphoma; Relapsed/Refractory Hairy Cell Leukemia
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: Brexucabtagene Autoleucel

Detailed Description

This study will use a basket study design with separate, indication-specific substudies, to investigate r/r RT and r/r BL.

After completing the treatment period, all participants will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.

All substudies have been early terminated by the sponsor. Below is summary of enrollment in each Substudy:

• Substudy-A This substudy was withdrawn. Therefore no participants were enrolled.
• Substudy-B enrollment closed, actual enrollment is 6.
• Substudy-C enrollment closed, actual enrollment is 12.
• Substudy-D enrollment closed, actual enrollment is 1.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 01090
    • Medical University of Vienna, Department of Internal Medicine I, Div. of Hematology
• France
  • Paris, France, 75013
    • Hopital de La Pitie Salpetriere
  • Toulouse, France, 31059
    • Centre hospitalier de Toulouse - Hematology department
• Germany
  • Cologne, Germany, 50937
    • Universitätsklinikum Köln
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm
• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna
  • Milan, Italy, 20162
    • Asst Grande Ospedale Metropolitano Niguarda
  • Perugia, Italy, 06132
    • Azienda Ospedale di Perugia - Ospedale S. Maria della Misericordia
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • Radboud University Nijmegen Medical Centre
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Seville, Spain, 41013
    • Hospital Universitario Virgen Del Rocio
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Istituto Oncologico Della Svizzera Italiana (IOSI)
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope (City of Hope National Medical Center)
    • Stanford, California, United States, 94305
      • Stanford Cancer Institute
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Georgetown University Medical Centre
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center - James Cancer HospitalS
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

All Substudies:

• Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Adequate hematologic and end-organ function.
• Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.

Substudy B:

• Confirmed diagnosis of chronic lymphocytic leukemia (CLL) based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria with histologically confirmed Richter transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype.

• Relapsed or refractory disease after 1 line of therapy, defined as at least 1 of the following:

  • Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy.
  • Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse.
• At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.

Substudy C:

• Histologically confirmed mature B-cell non-Hodgkin lymphoma (NHL) Burkitt lymphoma/leukemia.

• Relapsed or refractory disease after first-line chemoimmunotherapy, defined as 1 of the following:

  • Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy; individuals who are intolerant to first-line therapy are excluded.
  • Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse.
• At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.

Key Exclusion Criteria:

All Substudies:

• Prior chimeric antigen receptor (CAR) therapy or treatment with any anti-Cluster of Differentiation 19 (CD19) therapy.
• human immunodeficiency virus (HIV)-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/μL.
• Presence of detectable cerebrospinal fluid malignant cells or brain metastases.
• History of autoimmune disease (eg, Crohn's disease, rheumatoid arthritis, systemic lupus).

Substudy B:

• Diagnosis of RT not of DLBCL subtype (including, but not limited to, Hodgkin lymphoma (HL) and prolymphocytic leukemia).
• Prior allogeneic or autologous stem cell transplant < 3 months prior to screening and/or < 4 months prior to planned infusion of brexucabtagene autoleucel.
• Presence of active graft-versus-host disease following prior stem cell transplant.

Substudy C:

• Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, or high-grade B-cell lymphoma not otherwise specified.
• Prior allogeneic stem cell transplant < 3 months prior to screening and/or < 4 months prior to planned infusion of brexucabtagene autoleucel.
• Presence of active graft-versus-host disease following prior allogeneic stem cell transplant.
• Presence of central nervous system (CNS) involvement. Individuals with a prior history of CNS involvement are eligible if they show a negative cerebrospinal fluid (CSF) and no involvement by imaging.

Substudies A and D have been early terminated by the sponsor.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel; Participants with Relapsed/Refractory Waldenstrom Macroglobulinemia will receive the following treatment during the study:Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m^2/day intravenously (IV) and cyclophosphamide 500 mg/m^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) T cells/kg on Day 0.	Drug: Cyclophosphamide; Administered intravenously; Drug: Fludarabine; Administered intravenously; Biological: Brexucabtagene Autoleucel; Administered intravenously; Other Names: KTE-X19
Experimental: Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel; Participants with Relapsed/Refractory Richter Transformation will receive the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m^2/day IV and cyclophosphamide 500 mg/m^2/day IV for 3 days (Day -5 to Day -3).A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10^6 anti-CD19 CAR T cells/kg on Day 0.	Drug: Cyclophosphamide; Administered intravenously; Drug: Fludarabine; Administered intravenously; Biological: Brexucabtagene Autoleucel; Administered intravenously; Other Names: KTE-X19
Experimental: Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel; Participants with Relapsed/Refractory Burkitt Lymphoma will receive the following treatment during the study:Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m^2/day IV and cyclophosphamide 500 mg/m^2/day IV for 3 days (Day -5 to Day -3).A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10^6 anti-CD19 CAR T cells/kg on Day 0.	Drug: Cyclophosphamide; Administered intravenously; Drug: Fludarabine; Administered intravenously; Biological: Brexucabtagene Autoleucel; Administered intravenously; Other Names: KTE-X19
Experimental: Substudy D (Relapsed/Refractory hairy cell leukemia): Brexucabtagene Autoleucel; Participant with Relapsed/Refractory Hairy Cell Leukemia will receive the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m^2/day IV and cyclophosphamide 500 mg/m^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10^6 anti-CD19 CAR T cells/kg on Day 0.	Drug: Cyclophosphamide; Administered intravenously; Drug: Fludarabine; Administered intravenously; Biological: Brexucabtagene Autoleucel; Administered intravenously; Other Names: KTE-X19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substudy A: Combined Rate of Complete Response (CR) and Very Good Partial Response (VGPR) Determined by Central Assessment Per the Sixth International Workshop in Waldenstrom Macroglobulinemia (WM)	The combined rate of CR and VGPR was defined as the percentage of participants who achieved a best response of either CR or VGPR per the Sixth International Workshop in WM.	Up to 2 years
Substudy B: Objective Response Rate (ORR) Determined by Central Assessment Per the Lugano Classification	ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification.	Up to 2 years
Substudy C: ORR Determined by Central Assessment Per the Lugano Classification	ORR was defined as the percentage of participants who achieved a best response of either CR or PR per the Lugano Classification.	Up to 2 years
Substudy D: ORR Determined by Central Assessment Per the Response Criteria Described by Grever and Colleagues	ORR was defined as the percentage of participants who achieved a best response of either CR or PR per Grever and colleagues. CR: Near normalization of peripheral blood counts: hemoglobin >11 g/dL (without transfusion); platelets >100 000/μL; absolute neutrophil count >1500/μL. Regression of splenomegaly on physical examination. Absence of morphologic evidence of HCL on both the peripheral blood smear and the bone marrow examination. PR: PR required near normalization of the peripheral blood count (as in CR) with a minimum of 50% improvement in organomegaly and bone marrow biopsy infiltration with HCL.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment	CR Rate is defined as the percentage of participants with CR.	Up to 2 years
All Substudies (Substudies A, B, C and D): Duration of Response (DOR)	DOR was defined as time from first objective response (OR) to disease progression (PD) or death. OR is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). PD: 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 another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow.	Up to 2 years
All Substudies (Substudies A, B, C and D): Overall Survival (OS)	OS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of death from any cause.	Up to 2 years
All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS)	PFS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of PD or death from any cause. PD is defined in outcome measure #6.	Up to 2 years
All Substudies (Substudies A, B, C and D): Time to Next Treatment (TTNT)	TTNT defined as the time from the date of brexucabtagene autoleucel infusion to the start of new anti-cancer (including stem cell transplant) therapy prior to documented progression, or death from any cause. KM estimates were used in the outcome measure analysis.	Up to 2 years
All Substudies (Substudies A, B, C and D): Time to First Objective Response	Time to first objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of first response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D).	Up to 2 years
All Substudies (Substudies A, B, C and D): Time to Best Objective Response	Time to best objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of best response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D).	Up to 2 years
All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	TEAE was defined as any adverse event with onset on or after the brexucabtagene autoleucel infusion.	First infusion date of brexucabtagene autoleucel up to 2 years
All Substudies (Substudies A, B, C and D): Number of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher	Laboratory results were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE grading is a standardized system from the NCI that classifies the severity of side effects (adverse events) from cancer treatments, using a 1-5 scale: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death) The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized.	First infusion date of brexucabtagene autoleucel up to 2 years
All Substudies (Substudies A, B, C and D): Number of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher	Laboratory results were graded according to NCI CTCAE version 5.0. The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized.	First dose date up to 2 years
All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)	Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel-related events with onset within the first 28 days following brexucabtagene autoleucel infusion.	First infusion date of brexucabtagene autoleucel up to 28 days
All Substudies (Substudies A, B, C and D): Number of Participants With Positive Anti-brexucabtagene Autoleucel Antibodies		Up to 2 years
All Substudies (Substudies A, B, C and D): Number of Participants With Replication-competent Retrovirus (RCR) in Peripheral Blood Mononuclear Cells (PBMCs)		Up to 2 years
All Substudies (Substudies A, B, C and D): Number of Participants With Deterioration Scores From Screening in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)	EORTC QLQ-C30 is a quality of life (QOL) questionnaire for cancer participants, that has 30 items. 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties). Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. Participants with deterioration scores from screening for various questions of EORTC QLQ C-30 are reported. Deterioration was defined as scores at specific time point lesser than scores at baseline.	Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12
All Substudies (Substudies A, B, C and D): Number of Participants With Deterioration Scores From Screening in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L)	EQ-5D-5L was an instrument for use as a measure of health outcome. The EQ-5D-5L consisted of 2 sections: EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). EQ-5D comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Number of participants with deterioration scores from screening for each category are reported. Deterioration was defined as scores at specific time point lesser than scores at baseline.	Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12
All Substudies (Substudies A, B, C and D): Change From Screening in the EQ-ED-5L Visual Analogue Scale (EQ-VAS) Score	The EQ-VAS recorded the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine".	Screening, Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12
Substudy A: ORR (CR, VGPR, or PR) Determined by Central Assessment Per the Sixth International Workshop in WM	ORR was defined as the percentage of participants who achieved a best response of CR, VGPR, or PR per the Sixth International Workshop in WM.	Up to 2 years
Substudy A: Percentage of Participants With Combined CR and VGPR Determined by Investigator Assessment Per the Sixth International Workshop in WM	The combined rate of CR and VGPR was defined as the percentage of participants who achieved a best response of either CR or VGPR.	Up to 2 years
Substudy A: PR Rate Determined by Central Assessment Per the Sixth International Workshop in WM	PR rate was defined as percentage of participants who achieve PR.	Up to 2 years
Substudy A: VGPR Rate Determined by Central Assessment Per the Sixth International Workshop in WM	VGPR rate was defined as percentage of participants who achieve VGPR.	Up to 2 years
Substudy B: Number of Participants With OR Determined by Investigator Assessment Per the Lugano Classification	OR: CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (partial MR response (PMR)+partial RR(PRR)). CMR: score 1(no uptake above background)/2(uptake≤mediastinum)/3(uptake >mediastinum but ≤liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions,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 enlargement regress to normal; no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately>liver)/5(uptake markedly>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment. PRR:≥50% decrease in sum of product of diameters up to 6 target nodes and extra-nodal sites;absent/ normal,regressed,but no increase of NMLs;spleen regressed by>50% in length beyond normal.	Up to 2 years
Substudy B: Number of Participants With OR Based on Clonal Relationship to the Underlying CLL by Central Assessment Per the Lugano Classification	OR is defined as participants with CR or PR.	Up to 2 years
Substudy B: Number of Participants With OR (CR, CRi, or PR) Determined by Investigator Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 Criteria	OR was defined as the number of participants who achieved a best response of either CR, CRi, or PR by investigator assessment per IWCLL 2018 criteria. CR: Lymph nodes- none ≥1.5 cm; Liver or spleen size- Spleen size <13 cm; liver size normal; Constitutional symptoms, Circulating lymphocyte count- none; Platelet count- ≥100 × 109/L; Hemoglobin- ≥11.0 g/dL (untransfused and without erythropoietin); Marrow- Normocellular, no CLL cells, no B-lymphoid nodules. CRi: ; PR: Lymph nodes- Decrease ≥50% (from baseline); Liver or spleen size- Decrease ≥50% (from baseline); Constitutional symptoms- any, Circulating lymphocyte count- Decrease ≥50% from baseline; Platelet count- ≥100 × 109/L or increase ≥50% over baseline; Hemoglobin-≥11 g/dL or increase ≥50% over baseline; Marrow- Presence of CLL cells, or of B-lymphoid nodules, or not done.	Up to 2 years
Substudy C: Number of Participants With OR Determined by Investigator Assessment Per the Lugano Classification	OR was defined as the number of participants who achieved a best response of either CR or PR per the Lugano Classification. CR and PR per Lugano classification is defined in outcome measure #25.	Up to 2 years
Substudy D: Number of Participants With OR Determined by Investigator Assessment Per Grever and Colleagues	OR was defined as the number of participants who achieved a best response of either CR or PR per Grever and colleagues. CR: Near normalization of peripheral blood counts: hemoglobin >11 g/dL (without transfusion); platelets>100 000/μL; absolute neutrophil count >1500/μL. Regression of splenomegaly on physical examination. Absence of morphologic evidence of HCL on both the peripheral blood smear and the bone marrow examination. PR: PR required near normalization of the peripheral blood count (as in CR) with a minimum of 50% improvement in organomegaly and bone marrow biopsy infiltration with HCL.	Up to 2 years

Collaborators and Investigators

• Sponsor: Kite, A Gilead Company
• Investigators: Study Director: Kite Study Director, Kite, A Gilead Company

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): January 27, 2025
• Study Completion (Actual): January 27, 2025

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Infections; Virus Diseases; Neoplasms by Histologic Type; Hematologic Diseases; DNA Virus Infections; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia; Epstein-Barr Virus Infections; Herpesviridae Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Burkitt Lymphoma; Waldenstrom Macroglobulinemia; Leukemia, Hairy Cell; Organic Chemicals; Hydrocarbons; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclophosphamide; fludarabine; brexucabtagene autoleucel
• Other Study ID Numbers: KT-US-568-0138; 2022-501259-10 (Other Identifier: European Medicines Agency); 2022-501260-18 (Other Identifier: European Medicines Agency); 2022-501261-46 (Other Identifier: European Medicines Agency); 2022-501262-21 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No