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Relapsed/Refractory Mantle Cell LymphomaPhase 2JKART-1NCT06253663

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 study testing KTE-X19, Cyclophosphamide and Fludarabine in people with Relapsed/Refractory Mantle Cell Lymphoma and Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, run by Kite, A Gilead Company at 9 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KTE-X19, Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
9 sitesJapan
Study dates
18 Mar 2024to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Japan9 sites

  • Chiba University Hospital

    Chiba, 260-8677

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Hokkaido University Hospital

    Hokkaido, 060-8648,

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Okayama University Hospital

    Okayama, 700-8558

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Tokyo, 113-8677

Other trials in Japan

About this study

Official title: 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

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
Read the detailed description

After completing at least 24 months in the study, all participants who received an infusion of KTE-X19 will be transitioned to a separate long-term follow-up (LTFU) study (KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Being tested
KTE-X19, Cyclophosphamide, Fludarabine
Medical subject headings
Lymphoma, Mantle-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KTE-X19Drug

    Also called Tecartus

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

  • CyclophosphamideDrug

    Administered intravenously

  • FludarabineDrug

    Administered intravenously

Study groups in NCT06253663
Study groupRoleWhat they receive
MCL Cohort- KTE-X19ExperimentalParticipants 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.
Receives: Drug: KTE-X19; Drug: Cyclophosphamide; Drug: Fludarabine
ALL Cohort- KTE-X19ExperimentalParticipants 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.
Receives: Drug: KTE-X19; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

Secondary outcomes (12)

  1. MCL Cohort: Duration of Response (DOR)

    DOR is defined as time from first objective response to disease progression per indication specific response criteria or death from any cause.

    Measured: Up to 24 months

  2. MCL Cohort: Best Objective Response (BOR)

    BOR is defined as the incidence of CR, PR, Stable disease (SD) or progressive disease (PD) or unevaluable as best response to treatment.

    Measured: Up to 24 months

  3. MCL Cohort: Progression-Free Survival (PFS)

    PFS is defined as time from enrollment or KTE-X19 infusion to disease progression per indication specific response criteria or death from any cause.

    Measured: Up to 24 months

  4. MCL Cohort: Levels of Cytokines in Serum

    Measured: Up to Day 28

  5. ALL Cohort: Minimal Residual Disease (MRD) Negativity Rate

    The incidence of a minimal residual disease response (MRD-). MRD- is defined as MRD < 10^-6 per the standard assessment.

    Measured: Up to 24 months

  6. ALL Cohort: Allogeneic Stem Cell Transplant (alloSCT) rate

    The percentage of participants receiving alloSCT as the 1st next therapy after KTE-X19 infusion.

    Measured: Up to 24 months

  7. ALL Cohort: Relapse-Free Survival (RFS)

    RFS is defined as the time from enrollment or KTE-X19 infusion date to the date of disease relapse or death from any cause.

    Measured: Up to 24 months

  8. ALL Cohorts: DOR

    DOR is defined as the time between their first complete remission (CR or CRi) to relapse or any death in the absence of documented relapse.

    Measured: Up to 24 months

  9. MCL and ALL Cohort: Levels of Anti-Cluster of Differentiation 19 (Anti-CD19) CAR T Cells in Blood

    Measured: Up to 24 months

  10. MCL and ALL Cohorts: Percentages of Participants Experiencing Treatment-emergent Adverse Event (TEAEs), Serious Adverse Event (SAEs) and Deaths

    Measured: First infusion date up to 24 months

  11. MCL and ALL Cohorts: Overall Survival (OS)

    OS is defined as the time from enrollment or KTE-X19 infusion to death from any cause.

    Measured: Up to 24 months

  12. MCL and ALL Cohorts: Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values

    Measured: First infusion date up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start18 Mar 2024
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06253663
Sponsor's protocol ID
KT-US-472-0149
Acronym
JKART-1
Status last verified
Jun 2026
First submitted
2 Feb 2024
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KTE-X19, Cyclophosphamide and Fludarabine in people with Relapsed/Refractory Mantle Cell Lymphoma and Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, run by Kite, A Gilead Company at 9 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MCL Cohort: Objective Response Rate (ORR) Per Investigator Assessment (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06253663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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