Feasibility of leukapheresis for CAR T-cell production in heavily pre-treated pediatric patients.
CAR T-cells
Chimeric antigen receptor
Leukapheresis
Pediatric apheresis
Journal
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis
ISSN: 1473-0502
Titre abrégé: Transfus Apher Sci
Pays: England
ID NLM: 101095653
Informations de publication
Date de publication:
Aug 2020
Aug 2020
Historique:
received:
10
02
2020
revised:
26
03
2020
accepted:
26
03
2020
pubmed:
18
5
2020
medline:
9
6
2021
entrez:
17
5
2020
Statut:
ppublish
Résumé
Autologous CD19 chimeric-antigen receptor (CAR) T-cells are an effective salvage therapy for patients with relapsed or refractory B cell malignancies. The essential first step in the production is the collection of mature lymphocytes through leukapheresis. It is a challenging procedure given the fact patients are heavily pretreated and the special considerations of pediatric apheresis. We analyzed the data of leukapheresis outcome for CAR T production in a phase 1b/2 clinical trial enrolling 34 children, adolescents and young adults with relapsed or refractory B-cell malignancies. All patients underwent a single leukapheresis. Given a short production time for CAR T-cells, most patients received bridging therapy prior to apheresis. Leukapheresis was performed using peripheral venous access in the majority (82%) of patients, and the remainder required arterial line or central venous access. T-cell collection efficiency (CE) was variable with a median of 18%. No apheresis-related adverse events were noted, and all procedures were successful but two: one resulting in lower than target dose (1 × 10 Collection of sufficient T-cells in heavily pretreated pediatric patients via a single apheresis procedure is feasible even with relatively low T-cell CE.
Sections du résumé
BACKGROUND
BACKGROUND
Autologous CD19 chimeric-antigen receptor (CAR) T-cells are an effective salvage therapy for patients with relapsed or refractory B cell malignancies. The essential first step in the production is the collection of mature lymphocytes through leukapheresis. It is a challenging procedure given the fact patients are heavily pretreated and the special considerations of pediatric apheresis.
METHODS
METHODS
We analyzed the data of leukapheresis outcome for CAR T production in a phase 1b/2 clinical trial enrolling 34 children, adolescents and young adults with relapsed or refractory B-cell malignancies.
RESULTS
RESULTS
All patients underwent a single leukapheresis. Given a short production time for CAR T-cells, most patients received bridging therapy prior to apheresis. Leukapheresis was performed using peripheral venous access in the majority (82%) of patients, and the remainder required arterial line or central venous access. T-cell collection efficiency (CE) was variable with a median of 18%. No apheresis-related adverse events were noted, and all procedures were successful but two: one resulting in lower than target dose (1 × 10
CONCLUSIONS
CONCLUSIONS
Collection of sufficient T-cells in heavily pretreated pediatric patients via a single apheresis procedure is feasible even with relatively low T-cell CE.
Identifiants
pubmed: 32414613
pii: S1473-0502(20)30059-8
doi: 10.1016/j.transci.2020.102769
pii:
doi:
Substances chimiques
Receptors, Chimeric Antigen
0
Types de publication
Journal Article
Langues
eng
Pagination
102769Informations de copyright
Copyright © 2020 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest DH and EJ received honoraria from Novartis. All other authors have no conflicts of interest.