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

NCT06253663 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: KT-US-472-0149
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 9

Brief 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

Conditions

Relapsed/Refractory Mantle Cell Lymphoma; Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• MCL Cohort: Objective Response Rate (ORR) Per Investigator Assessment

  ORR is defined as the incidence of a complete remission (CR) or a partial remission (PR) per the Lugano Classification.

  Up to 24 months

• ALL Cohort: Overall Complete Remission (OCR) Rate

  OCR rate is defined as the percentage of participants achieving CR/complete remission with incomplete hematologic recovery (CRi) per investigator assessment.

  Up to 24 months

Secondary Outcomes (12)

• MCL Cohort: Duration of Response (DOR)

  Up to 24 months

• MCL Cohort: Best Objective Response (BOR)

  Up to 24 months

• MCL Cohort: Progression-Free Survival (PFS)

  Up to 24 months

• MCL Cohort: Levels of Cytokines in Serum

  Up to Day 28

• ALL Cohort: Minimal Residual Disease (MRD) Negativity Rate

  Up to 24 months

Study Arms (2)

MCL Cohort- KTE-X19

EXPERIMENTAL

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.

Drug: KTE-X19; Drug: Cyclophosphamide; Drug: Fludarabine

ALL Cohort- KTE-X19

EXPERIMENTAL

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.

Drug: KTE-X19; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

KTE-X19 DRUG

A single infusion of chimeric antigen receptor (CAR) T cells

Also known as: Tecartus

ALL Cohort- KTE-X19; MCL Cohort- KTE-X19

Cyclophosphamide DRUG

Administered intravenously

ALL Cohort- KTE-X19; MCL Cohort- KTE-X19

Fludarabine DRUG

Administered intravenously

ALL Cohort- KTE-X19; MCL Cohort- KTE-X19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kite, A Gilead Company: lead

Study Sites (9)

Chiba University Hospital

Chiba, 260-8677, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648,, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Tokyo, 113-8677, Japan

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Recurrence

Interventions

brexucabtagene autoleucel; Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Kite Study Director

  Kite, A Gilead Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participant will be enrolled into the appropriate cohort depending on the type of disease in the two cohorts: r/r Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic Leukemia(B-ALL)

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: March 18, 2024
• Primary Completion: November 20, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (9)