Evidence map›Paper›PMID 40908464›Full record

ArticleThe AAPS journal2025

Cellular Immunogenicity Assessments in CAR-T Cell Therapies: Current Insights and Future Directions.

Madhan Masilamani, Nanda Balasubramanian, Johanna Mora, Alice Park, Vibha Jawa

Abstract read
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In one paragraph

Article in The AAPS journal, 2025. 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

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

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

5 authors.

Madhan MasilamaniPrecision Medicine Bioanalytical & Translational Sciences, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA. madhan.masilamani@bms.com.ORCID 0000-0001-8181-8848
Nanda BalasubramanianPrecision Medicine Bioanalytical & Translational Sciences, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA.ORCID 0009-0005-2199-3122
Johanna MoraPrecision Medicine Bioanalytical & Translational Sciences, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA.ORCID 0000-0001-6853-2263
Alice ParkPrecision Medicine Bioanalytical & Translational Sciences, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA.ORCID 0009-0001-2147-7567
Vibha JawaPrecision Medicine Bioanalytical & Translational Sciences, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA.ORCID 0000-0001-7019-729X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

CAR-T-cells can drive MHC class-I-mediated CD8 + cytotoxic T-cell response towards CAR constructs in addition to an antibody response. Immune response may also develop towards residuals present in the CAR-T cell product such as AAV, CRISPR/CAS9, and expamers. Health authorities recommend developing assays to assess both humoral and cellular immunogenicity towards the CAR-T protein. For the assessment of a humoral response, scientists can leverage the guidance and experience from anti-drug antibody (ADA) assays being developed for biologics. However, measuring CAR-T induced cellular immune responses may be challenging due to factors like cell survival, assay variability, lack of relevant positive controls, reagents, etc. This commentary overviews the strategy for investigating cellular immunogenicity for CAR-T products in development, describing the process for risk assessment, guidance on sample collection, including logistics of cell processing and handling, and design of CAR domain related peptides to elicit the memory response from dosed subjects. The experience gained from cellular immunogenicity assessments implemented for ongoing CAR-T-cell therapies and challenges encountered are presented with concrete recommendations, without disclosure of proprietary data. The clinical relevance/impact of assessing cellular immunogenicity for CAR-T therapies and any association with humoral response will also be delineated.

Indexed as

Immunity, CellularImmunotherapy, AdoptiveReceptors, Chimeric AntigenT-LymphocytesAnimalsHumansImmunity, HumoralRisk AssessmentReceptors, Chimeric AntigenCAR-T cellscytotoxic T-lymphocyte responseELISpotIFN-γimmunogenicity

Identifiers

PMID40908464

What OpenQuestion holds

Textmetadata
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.