Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
NCT ID: NCT06253663
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2024-03-18
2027-07-31
Brief Summary
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The primary objectives of this study are to evaluate the efficacy of KTE-X19, as measured by:
* Objective response rate (ORR) per investigator assessment, in adult Japanese participants with r/r MCL
* Overall complete remission (OCR) defined as complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per investigator assessment, in adult Japanese participants with r/r ALL
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MCL Cohort- KTE-X19
Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepletion chemotherapy for 3 days followed by KTE-X19 administered intravenously at a target dose of 2 x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) T cells/kg on Day 0.
For participants weighing ≥ 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells will be administered.
KTE-X19
A single infusion of chimeric antigen receptor (CAR) T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
ALL Cohort- KTE-X19
Participants will receive cyclophosphamide 900 mg/m\^2/day intravenously (IV) for 1 day and fludarabine 25 mg/m\^2/day IV lymphodepletion chemotherapy for 3 days followed by KTE-X19 administered intravenously at a target dose of 1 x 10\^6 19 CAR T cells/kg on Day 0.
For participants weighing ≥ 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells will be administered.
KTE-X19
A single infusion of chimeric antigen receptor (CAR) T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Interventions
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KTE-X19
A single infusion of chimeric antigen receptor (CAR) T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or presence of t(11;14)
* Up to 5 prior regimens for MCL. Prior therapy must have included:
* Anthracycline-, bendamustine-, or high-dose cytarabine- containing chemotherapy, and
* Anti-CD20 monoclonal antibody therapy, and
* Bruton's tyrosine kinase inhibitor (BTKi)
* Relapsed or refractory disease, defined by the following:
* Disease progression after last regimen, or
* Refractory disease is defined failure to achieve partial response (PR) or complete remission (CR) to the last regimen
* At least 1 measurable lesion. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
* If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 2 cm
ALL Cohort:
* Relapsed or refractory B-ALL defined as one of the following:
* Relapsed or refractory disease after one line of systemic therapy;
* Primary refractory, or
* First relapse if first remission ≤ 12 months
* Relapsed or refractory disease after two or more lines of systemic therapy
* Relapsed or refractory disease after allogeneic transplant provided individuals is at least 100 days from SCT at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
* Morphological disease in the bone marrow (\> 5% blasts)
* Individuals with Philadelphia-positive (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
Exclusion Criteria
* History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease-free for at least 3 years
* Autologous SCT (autoSCT) within 6 weeks of planned KTE-X19 infusion
* History of alloSCT with the exception of individuals with no donor cells detected on chimerism \> 100 days after alloSCT
* Prior CD19 targeted therapy
* Prior CAR therapy or other genetically modified T-cell therapy
* History of hypersensitivity to any of the ingredients of KTE-X19 or to any of the animal-derived ingredients (bovine and rodent) used in the manufacturing process of KTE-X19
ALL Cohort:
* Diagnosis of Burkitt's leukemia/lymphoma according to 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 (eg, cervix, bladder, breast) unless disease free for at least 3 years
* History of hypersensitivity to any of the ingredients of KTE-X19 or to any of the animal-derived ingredients (bovine and rodent) used in the manufacturing process of KTE-X19
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
Responsible Party
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Principal Investigators
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Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
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Chiba University Hospital
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Kyoto University Hospital
Kyoto, , Japan
Tohoku University Hospital
Miyagi, , Japan
Okayama University Hospital
Okayama, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Juntendo University Hospital
Tokyo, , Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, , Japan
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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KT-US-472-0149
Identifier Type: -
Identifier Source: org_study_id