Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
NCT05776134 · Status: AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2026-04-08
Summary
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
Conditions
Interventions
- BIOLOGICAL
-
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
Sponsors & Collaborators
-
Kite, A Gilead Company
lead INDUSTRY
Principal Investigators
-
Kite Study Director · Kite, A Gilead Company
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
More Related Trials
-
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies
NCT05537766 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
NCT03624036 ·Status: TERMINATED ·Phase: PHASE1
-
Expanded Access Program for OOS Obe-cel
NCT06799221 ·Status: AVAILABLE
-
US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT05627466 ·Status: NO_LONGER_AVAILABLE
-
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
NCT01466179 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
NCT00560794 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL
NCT03740529 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting
NCT06788639 ·Status: RECRUITING
-
Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence
NCT05310591 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients
NCT02010931 ·Status: COMPLETED
-
Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
NCT00003861 ·Status: ACTIVE_NOT_RECRUITING
-
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
NCT06533761 ·Status: RECRUITING ·Phase: PHASE1
-
Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)
NCT00593944 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of a New Anti-cancer Immunotherapy in Adult Acute Myeloid Leukemia Patients With a Suboptimal Clinical Response to Induction Chemotherapy
NCT01051063 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)
NCT05470140 ·Status: COMPLETED ·Phase: PHASE1
-
Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)
NCT01001143 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Mana 312 (Multi Tumor-Associated Antigen T Cells) in Adults With AML/MDS After HSCT
NCT04679194 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase
NCT00449761 ·Status: TERMINATED ·Phase: PHASE2
-
Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL
NCT02187354 ·Status: NO_LONGER_AVAILABLE
-
A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia
NCT01773408 ·Status: COMPLETED ·Phase: PHASE1
-
Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid Leukemia
NCT00718159 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Efficacy and Safety of CTL019 in Adult ALL Patients
NCT02167360 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)
NCT05460533 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
NCT00621244 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Open-label, Dose-Escalation and Dose-Expansion Study of GB3226 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT07084584 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2