Evidence map›Paper›PMID 39304595›Full record

ArticleEuropean journal of drug metabolism and pharmacokinetics2024

Prediction of First-in-Human Dose of Chimeric Antigen Receptor-T (CAR-T) Cells from Mice.

Iftekhar Mahmood

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Article in European journal of drug metabolism and pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Iftekhar MahmoodMahmood Clinical Pharmacology Consultancy, LLC, 1709, Piccard DR, Rockville, MD, 20850, USA. Iftekharmahmood@aol.com.ORCID http://orcid.org/0000-0003-1311-4237

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveCurrently, there is no available method for the prediction of first-in-human (FIH) dose for chimeric antigen receptor-T (CAR-T) cells. The objective of this work was to predict the FIH dose of CAR-T cells from different doses given to mice.

methodsIn this study, six scaling methods were evaluated for the prediction of FIH dose for CAR-T cells. The methods were body weight-based fixed exponents such as 1.0 and 0.75, human equivalent dose (HED) using exponents 0.33, two modified HED methods such as using total animal dose (in place of per kg basis) and body surface area in place of body weight using total animal dose with exponent 0.33 and a physiological factor derived from physiological parameters. The FIH doses of six CAR-T cells were predicted in this study. The predicted human doses were compared with the recommended human dose by the US-FDA for four CAR-T cell products, and the literature data were used for the remaining two CAR-T cells.

resultsThe results indicated that the two modified HED methods and physiological factor are the best and reliable methods for the prediction of FIH dose for CAR-T cells.

conclusionsThe proposed methods are simple and accurate in their predictive power and can be used on a spreadsheet.

Indexed as

Immunotherapy, AdoptiveReceptors, Chimeric AntigenAnimalsBody WeightHumansMiceT-LymphocytesReceptors, Chimeric Antigen

Identifiers

PMID39304595

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.