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Trial Title:
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
Condition:
Relapsed/Refractory Mantle Cell Lymphoma
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Mantle-Cell
Cyclophosphamide
Fludarabine
Brexucabtagene autoleucel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention 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)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KTE-X19
Description:
A single infusion of chimeric antigen receptor (CAR) T cells
Arm group label:
ALL Cohort- KTE-X19
Arm group label:
MCL Cohort- KTE-X19
Other name:
Tecartus
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Administered intravenously
Arm group label:
ALL Cohort- KTE-X19
Arm group label:
MCL Cohort- KTE-X19
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Administered intravenously
Arm group label:
ALL Cohort- KTE-X19
Arm group label:
MCL Cohort- KTE-X19
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
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chiba University Hospital
Address:
City:
Chiba
Zip:
260-8677
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Hokkaido
Zip:
060-8648,
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyoto University Hospital
Address:
City:
Kyoto
Zip:
606-8507
Country:
Japan
Status:
Recruiting
Facility:
Name:
Tohoku University Hospital
Address:
City:
Miyagi
Zip:
980-8574
Country:
Japan
Status:
Recruiting
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Juntendo University Hospital
Address:
City:
Tokyo
Zip:
113-8431
Country:
Japan
Status:
Recruiting
Start date:
March 18, 2024
Completion date:
May 2027
Lead sponsor:
Agency:
Kite, A Gilead Company
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06253663
https://www.gileadclinicaltrials.com/study?nctid=NCT06253663
