Trials / Active Not Recruiting
Active Not RecruitingNCT06253663
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 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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Kite, A Gilead Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Relapsed/Refractory Mantle Cell Lymphoma
- Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KTE-X19 | A single infusion of chimeric antigen receptor (CAR) T cells |
| DRUG | Cyclophosphamide | Administered intravenously |
| DRUG | Fludarabine | Administered intravenously |
Timeline
- Start date
- 2024-03-18
- Primary completion
- 2025-11-20
- Completion
- 2027-07-01
- First posted
- 2024-02-12
- Last updated
- 2025-12-16
Locations
9 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06253663. Inclusion in this directory is not an endorsement.