Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Public ClinicalTrials.gov record NCT03624036. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL) who have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor. After the end of KTE-C19-108, participants who received an infusion of brexucabtagene autoleucel will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968 (NCT05041309).
Study identification
- NCT ID
- NCT03624036
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Interventions
- brexucabtagene autoleucel Biological
- Fludarabine Drug
- Cyclophosphamide Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 14, 2018
- Primary completion
- Feb 11, 2021
- Completion
- Nov 17, 2022
- Last update posted
- Nov 17, 2023
2018 – 2022
United States locations
- U.S. sites
- 21
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic - Arizona | Phoenix | Arizona | 85054 | — |
| University of California Los Angeles (UCLA) | Los Angeles | California | 90095 | — |
| Stanford University | Stanford | California | 94035 | — |
| Sarah Cannon - Denver | Denver | Colorado | 80218 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Memorial Sloan-Kettering | New York | New York | 10021 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Cleveland Clinic - Taussig Cancer Institute | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Sarah Cannon Research Center | Nashville | Tennessee | 37203 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| Baylor Cancer Hospital | Dallas | Texas | 75246 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03624036, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 17, 2023 · Synced Sep 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03624036 live on ClinicalTrials.gov.