Evidence map›Paper›PMID 38953939›Full record

ArticleCancer immunology, immunotherapy : CII2024

In vitro CAR-T cell killing: validation of the potency assay.

Claudia Piccinini, Silvia Carloni, Chiara Arienti, Elena Pancisi, Francesca Fanini, Sara Pignatta, Valentina Soldati, Monica Stefanelli, Anna Maria Granato, Giovanni Martinelli and 2 more

Abstract readValidation Study
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

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.

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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. 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

12 authors.

Claudia Piccinini *Immuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.ORCID http://orcid.org/0000-0001-5862-6207
Silvia Carloni *Immuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.ORCID http://orcid.org/0000-0003-1646-7134
Chiara ArientiImmuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.ORCID http://orcid.org/0000-0002-2265-828X
Elena PancisiImmuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.ORCID http://orcid.org/0000-0002-8780-2342
Francesca FaniniImmuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.ORCID http://orcid.org/0000-0002-3903-9514
Sara PignattaImmuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy. sara.pignatta@irst.emr.it.ORCID http://orcid.org/0000-0001-5464-0052
Valentina SoldatiImmuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.
Monica StefanelliImmuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.
Anna Maria GranatoImmuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.ORCID http://orcid.org/0000-0002-8609-4217
Giovanni MartinelliScientific Direction, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.ORCID http://orcid.org/0000-0002-1025-4210
Laura RidolfiExperimental and Clinical Oncology of Immunotherapy and Rare Cancer Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.ORCID http://orcid.org/0000-0003-1870-3380
Massimiliano PetriniImmuno-Gene Therapy Factory, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Via Maroncelli 40, 47014, Meldola, Italy.ORCID http://orcid.org/0000-0002-8942-0890

Funding

Ministero della Salute PNC-E3-2022-23683269 PNC-HLS-TA
6 · The paper itself

Abstract

For advanced therapy medicinal products, the development and validation of potency assays are required, in accordance with international guidelines, to characterise the product and obtain reliable and consistent data. Our purpose was to validate the killing assay for the evaluation of autologous anti-CD19 chimeric antigen receptor (CAR) T potency. We used CD4 + and CD8 + lymphocytes or anti-CD19 CAR-T cells as effector cells and REH (CD19 +) or MOLM-13 (CD19 -) cell lines as target cells. After co-culturing target and effector cells (1:1 ratio) for 24 h, samples were labelled with 7-AAD, anti-CD3 and anti-CD19 antibodies and the frequency of CD19 + dead cells was evaluated by flow cytometry. In order to verify the CAR-T specificity for the CD19 + target, the co-culture between CAR-T and REH or MOLM-13 at different effector-to-target ratios was scheduled. Moreover, not transduced CD4 + and CD8 + lymphocytes were tested in comparison with CAR-T from the same donor to demonstrate the assay specificity. Linearity and accuracy were evaluated, and established acceptance criteria were compiled for both parameters (r

Indexed as

Antigens, CD19Immunotherapy, AdoptiveReceptors, Chimeric AntigenCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCell Line, TumorCoculture TechniquesCytotoxicity, ImmunologicHumansAntigens, CD19Receptors, Chimeric AntigenCAR-TKillingPotencyValidation

Identifiers

PMID38953939
PMCPMC11219661

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.