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Active, not recruiting Phase 2

Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

NCT06253663 · tracked via the Priya Life Science Japan tracker
Phase
Phase 2
Started
2024-03-18
Last updated
2026-06-25

Condition(s) studied

Relapsed/Refractory Mantle Cell LymphomaRelapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

KTE-X19 →Cyclophosphamide →Fludarabine →

KTE-X19: A single infusion of chimeric antigen receptor (CAR) T cells

Cyclophosphamide: Administered intravenously

Fludarabine: Administered intravenously

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • MCL Cohort: Objective Response Rate (ORR) Per Investigator Assessment — Up to 24 months
    ORR is defined as the incidence of a complete remission (CR) or a partial remission (PR) per the Lugano Classification.
  • ALL Cohort: Overall Complete Remission (OCR) Rate — Up to 24 months
    OCR rate is defined as the percentage of participants achieving CR/complete remission with incomplete hematologic recovery (CRi) per investigator assessment.

Trial sites (9)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06253663 on ClinicalTrials.gov ↗ ← All trials in Japan