Phase I CAR-T Clinical Trials Review.
Anticancer Res
; 42(12): 5673-5684, 2022 Dec.
Article
em En
| MEDLINE
| ID: mdl-36456127
ABSTRACT
BACKGROUND/AIM:
Chimeric antigen receptor (CAR) T cells with tumor specificity are being increasingly investigated. Phase I trials are the first step of testing for safety of novel CAR-T therapy to determine the maximum tolerated dose (MTD). Several dose escalation methods have been developed over time including rule-based, model-based, and model-assisted designs. The goal of this project is to overview the phase I designs used in current CAR-T trials. MATERIALS ANDMETHODS:
We searched PubMed for peer-reviewed literature published between January 1, 2015 and December 31, 2021. The search was limited to human studies in the English language using the keywords "CAR-T phase I", "clinical trials", and "full text".RESULTS:
One hundred nine papers with at least partial phase I components were included for analysis. 31.2% of the trials used the traditional 3+3 or a variation of said design, and 60.6% did not mention the dose escalation design. The majority of the manuscripts (59.6%) did not report cohort size while 19.3% did not specify the timing of evaluation. Although most of the studies were registered with CT.gov, only 33.9% had any results submitted or posted to CT.gov These trends persisted even in manuscripts published in journals with high impact factors.CONCLUSION:
Standardizing the publication criteria and providing basic elements of phase I clinical trials are critical to ensure high quality of manuscripts. With the quick development and high costs of CAR-T cell therapy, adoption of advanced designs such as model-based and model-assisted should increase to improve efficiency of clinical trials.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Receptores de Antígenos Quiméricos
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article