Evidence map›Paper›PMID 34125421›Full record

ArticleClinical pharmacokinetics2021

Population Cellular Kinetics of Lisocabtagene Maraleucel, an Autologous CD19-Directed Chimeric Antigen Receptor T-Cell Product, in Patients with Relapsed/Refractory Large B-Cell Lymphoma.

Ken Ogasawara, Michael Dodds, Timothy Mack, James Lymp, Justine Dell'Aringa, Jeff Smith

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02631044 (A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 7% of its field
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

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02631044 phase1completednot on this map

A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

TypeinterventionalSponsorJuno Therapeutics, a Subsidiary of CelgeneRan2016 to 2024Enrolled387ConditionsNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle-cell LymphomaArmsJCAR017 (lisocabtagene maraleucel) single-dose schedule, JCAR017 (lisocabtagene maraleucel) 2-dose schedule
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Ken OgasawaraBristol Myers Squibb, Princeton, NJ, USA. ken.ogasawara@bms.com.ORCID 0000-0002-4264-8927
Michael DoddsCertara, Princeton, NJ, USA.
Timothy MackBristol Myers Squibb, Princeton, NJ, USA.
James LympBristol Myers Squibb, Seattle, WA, USA.
Justine Dell'AringaBristol Myers Squibb, Seattle, WA, USA.
Jeff SmithBristol Myers Squibb, Seattle, WA, USA.
Bristol-Myers Squibb (United States) · USCertara (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesLisocabtagene maraleucel (liso-cel) is a CD19-directed, defined composition, 4-1BB chimeric antigen receptor (CAR) T-cell product administered at equal target doses of CD8

methodsWe employed nonlinear mixed-effects modeling to develop a population cellular kinetic model for liso-cel. The population cellular kinetic analysis was performed using 2524 post-infusion transgene observations from 261 patients with relapsed/refractory large B-cell lymphoma who were treated with a single dose of liso-cel in TRANSCEND NHL 001. Covariates for the analysis included baseline intrinsic factors such as age, baseline disease characteristics, and liso-cel and coadministration factors.

resultsLiso-cel cellular kinetics were well described by a piecewise model of cellular growth kinetics that featured lag, exponential growth, and biexponential decay phases. Population means (95% confidence interval) of lag phase duration, doubling time, time to maximum levels, initial decline half-life, and terminal half-life were 3.27 (2.71-3.97), 0.755 (0.667-0.821), 9.29 (8.81-9.70), 5.00 (4.15-5.90), and 352 (241-647) days, respectively. The magnitude of effect on liso-cel expansion metrics demonstrated that the covariate associations were smaller than the residual between-subject variability in the population.

conclusionsThe covariates tested were not considered to have a meaningful impact on liso-cel kinetics. CLINICAL

trial registrationNCT02631044.

Indexed as

Lymphoma, Large B-Cell, DiffuseReceptors, Chimeric AntigenAntigens, CD19HumansKineticsReceptors, Antigen, T-CellT-LymphocytesAntigens, CD19Receptors, Antigen, T-CellReceptors, Chimeric Antigen

Identifiers

PMID34125421
PMCPMC8613160
OpenAlexW3166894073

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.