Study Details

OVERVIEW

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 (JKART-1)

PROTOCOL 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

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

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

Gender

N/A

Date

March 2024 - May 2027

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

KTE-X19, Cyclophosphamide, Fludarabine

Eligibility Information

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

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.

Locations

Locations (9)

Chiba University Hospital

Chiba, Japan, 260-8677

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Hokkaido University Hospital

Hokkaido, Japan, 060-8648,

Kyoto University Hospital

Kyoto, Japan, 606-8507

Tohoku University Hospital

Miyagi, Japan, 980-8574

Okayama University Hospital

Okayama, Japan, 700-8558

National Cancer Center Hospital

Tokyo, Japan, 104-0045

Juntendo University Hospital

Tokyo, Japan, 113-8431

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Tokyo, Japan, 113-8677

Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (JKART-1)