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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
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL).

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma Biological: brexucabtagene autoleucel (KTE-X19) Drug: Fludarabine Drug: Cyclophosphamide Phase 1

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: brexucabtagene autoleucel (KTE-X19)
Participants will receive conditioning chemotherapy (fludarabine and cyclophosphamide), followed by the investigational treatment, brexucabtagene autoleucel (KTE-X19).
 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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicity (DLTs) in participants treated with brexucabtagene autoleucel (KTE-X19) [ Time Frame: Within first 28 days following infusion ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) per Investigator Review [ Time Frame: Up to 15 years ]
    Objective response rate is defined per the IWCLL 2018 criteria.

  2. Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 years ]
  3. Levels of Anti-CD19 CAR T-Cells in Blood [ Time Frame: Up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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)

  • 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

  • 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:

  • 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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Kite, A Gilead Company
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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