Evidence map›Paper›PMID 41254345›Full record

ArticleThe AAPS journal2025

Leveraging in vitro Tumor Cell Killing and Cytokine Release to Predict Cytokine Release Syndrome Associated with CD3 T-cell Bispecifics in Oncology: a Retrospective Analysis.

Apolline Lefèvre, Zinnia P Parra-Guillen, Iñaki F Trocóniz, Christophe Boetsch, Nicolas Frances

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Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Apolline LefèvreRoche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel, 4070, Switzerland. apolline.lefevre@roche.com.ORCID 0009-0000-2581-1086
Zinnia P Parra-GuillenPharmacometrics & Systems Pharmacology, Department of Pharmaceutical Science. School of Pharmacy and Nutrition, University of Navarra, Pamplona, 31009, Spain.ORCID 0000-0003-1503-2710
Iñaki F TrocónizPharmacometrics & Systems Pharmacology, Department of Pharmaceutical Science. School of Pharmacy and Nutrition, University of Navarra, Pamplona, 31009, Spain.ORCID 0000-0003-3700-8658
Christophe BoetschRoche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel, 4070, Switzerland.ORCID 0009-0005-8467-0339
Nicolas FrancesRoche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, Basel, 4070, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

While T-cell Bispecifics (TCBs) are promising molecules for cancer treatment, their clinical development remains challenging due to Cytokine Release Syndrome (CRS). There is currently no method to accurately predict the doses expected to trigger CRS from pre-clinical data, resulting in the selection of non optimal First-In-Human (FIH) doses, far from the doses expected to show clinical benefit, to address safety concerns. In this work, a retrospective analysis aiming to identify which in vitro assay (focusing on tumor cell killing and cytokine release) is predictive of CRS at the first administration of TCBs developed for oncology indications at Roche is presented. A concentration threshold of C

Indexed as

Antibodies, BispecificCD3 ComplexCytokine Release SyndromeCytokinesNeoplasmsT-LymphocytesCell Line, TumorDose-Response Relationship, DrugHumansRetrospective StudiesAntibodies, BispecificCD3 ComplexCytokinesCytokine Release SyndromePharmacokinetic/Pharmacodynamic (PKPD)Pre-clinical to clinical translationT-cell bispecifics

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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.