Clinical trial · Interventional
Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
A Phase 2 Multicenter Study Evaluating the Safety and the Efficacy of KTE-X19 in Adult Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic Leukemia (B-ALL). 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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
| Relapsed/Refractory Mantle Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| KTE-X19 | Drug | Brexucabtagene Autoleucel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MCL Cohort- KTE-X19
- description
- 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.
- interventionNames
- Drug: KTE-X19
- Drug: Cyclophosphamide
- Drug: Fludarabine
- type
- EXPERIMENTAL
- label
- ALL Cohort- KTE-X19
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria:
MCL Cohort:
* 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
Key Exclusion Criteria:
MCL Cohort:
* 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
Note: Other protocols defined Inclusion/Exclusion criteria may apply.References
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