Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ZUMA-8)
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ClinicalTrials.gov Identifier: NCT03624036 |
Recruitment Status :
Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : April 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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Relapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma | Biological: brexucabtagene autoleucel (KTE-X19) Drug: Fludarabine Drug: Cyclophosphamide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
Actual Study Start Date : | November 15, 2018 |
Estimated Primary Completion Date : | February 2022 |
Estimated Study Completion Date : | February 2037 |

Arm | Intervention/treatment |
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Experimental: brexucabtagene autoleucel (KTE-X19)
Participants will receive conditioning chemotherapy (fludarabine and cyclophosphamide), followed by the investigational treatment, brexucabtagene autoleucel (KTE-X19).
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Biological: brexucabtagene autoleucel (KTE-X19)
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously Drug: Fludarabine Administered intravenously Drug: Cyclophosphamide Administered intravenously |
- Incidence of Dose Limiting Toxicity (DLTs) in participants treated with brexucabtagene autoleucel (KTE-X19) [ Time Frame: Within first 28 days following infusion ]
- Objective Response Rate (ORR) per Investigator Review [ Time Frame: Up to 15 years ]Objective response rate is defined per the IWCLL 2018 criteria.
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 years ]
- Levels of Anti-CD19 CAR T-Cells in Blood [ Time Frame: Up to 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
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Documentation of relapsed or refractory CLL and SLL; must have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor.
- Cohort 1 and 2: Subjects with r/r CLL who have received at least 2 prior lines of treatment, one of which must include a BTK inhibitor.
- Cohort 3: Subjects with r/r CLL and SLL must present with ≤ 1% circulating tumor cells in peripheral blood or ALC < 5000 cells/μL. Subjects must have received at least 2 prior lines of treatment, one of which must include a BTK inhibitor.
- Cohort 4: Subjects with r/r CLL who have received at least 2 prior lines of treatment and must have received ibrutinib as a single agent or in comibation with anti-CD20 antibodies, BCL-2 inhibitors, and PI3k inhibitors for at least 6 months as the last line of therapy prior to screening. Ibrutinib administration will continue up to 30 hours prior to leukapheresis. In case of treatment interruption with ibrutinib, the principal investigator should reach out to the medical monitor to discuss.
- An indication for treatment per IWCLL 2018 criteria and radiographically measurable disease (at least 1 lesion > 1.5 cm in diameter)
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Adequate hematologic function as indicated by:
- Platelet count ≥ 50 × 10^9/L
- Neutrophil count ≥ 0.5 × 10^9/L
- Hemoglobin ≥ 8 g/dL unless lower values are attributable to CLL
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Adequate renal, hepatic, cardiac and pulmonary function defined as:
- Creatinine clearance (as estimated by Cockcroft-Gault) ≥ 60 mL/min
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL unless subject has Gilbert's syndrome
- Left ventricular ejection fraction (LVEF) ≥ 50%, no evidence of pericardial effusion, no New York Heart Association (NYHA) class III or IV functional classification, no clinically significant arrhythmias
- No clinically significant pleural effusion
- Baseline oxygen saturation > 92% on room air
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy or BTKi (ibrutinib or acalabrutinib) at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists)
Key Exclusion Criteria:
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A history of treatment including any of the following:
- Prior CD19 directed therapy
- Prior allogeneic hematopoietic stem cell transplant (SCT) or donor lymphocyte infusion (DLI) within 6 months prior to enrollment
- History of autoimmune disease resulting in end-organ injury unless attributable to CLL (eg, idiopathic thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA))
- Diagnosis of Richter's transformation or a history of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, skin, cervix, bladder, breast), superficial bladder cancer, asymptomatic localized low grade prostate cancer for which watch-and-wait approach is standard of care, or any other cancer that has been in remission for > 3 years prior to enrollment
- History of severe hypersensitivity reaction attributed to aminoglycosides
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624036

Study Director: | Gilead Study Director | Gilead Sciences |
Responsible Party: | Kite, A Gilead Company |
ClinicalTrials.gov Identifier: | NCT03624036 |
Other Study ID Numbers: |
KTE-C19-108 2018-001923-38 ( EudraCT Number ) |
First Posted: | August 9, 2018 Key Record Dates |
Last Update Posted: | April 14, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell |
Cyclophosphamide Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |