Evidence map›Paper›PMID 41746943›Full record

ArticlePloS one2026

A phase I clinical trial to evaluate the tolerability and safety of an allogeneic iPSC-derived iNKT cell and α-GalCer-pulsed autologous DC combination therapy for patients with recurrent and advanced head and neck cancer: A study protocol.

Tomoya Kurokawa, Tomohisa Iinuma, Haruna Ebisu, Tomoha Yanagidaira, Yosuke Inaba, Tadami Fujiwara, Yoko Hattori, Tominaga Fukazawa, Takahiro Aoki, Haruhiko Koseki and 3 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2026. 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

13 authors.

Tomoya KurokawaClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.ORCID https://orcid.org/0009-0002-8996-4676
Tomohisa IinumaDepartment of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan.
Haruna EbisuClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Tomoha YanagidairaClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Yosuke InabaClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Tadami FujiwaraClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Yoko HattoriClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Tominaga FukazawaLaboratory for Developmental Genetics, RIKEN Center for Integrative Medical Sciences, Yokohama, Kanagawa, Japan.
Takahiro AokiLaboratory for Developmental Genetics, RIKEN Center for Integrative Medical Sciences, Yokohama, Kanagawa, Japan.
Haruhiko KosekiLaboratory for Developmental Genetics, RIKEN Center for Integrative Medical Sciences, Yokohama, Kanagawa, Japan.
Hideki HanaokaClinical Research Center, Chiba University Hospital, Chiba, Chiba, Japan.
Toyoyuki HanazawaDepartment of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan.
Shinichiro MotohashiDepartment of Medical Immunology, Graduate School of Medicine, Chiba University, Chiba, Chiba, Japan.ORCID https://orcid.org/0000-0002-9332-3129

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Natural killer T (NKT) cells show intense tumor-killing activity through direct and indirect pathways. However, humans have less than 0.01% of NKT cells in the peripheral blood, making it difficult to apply NKT cells for cancer treatment. We have successfully produced invariant NKT cells derived from induced pluripotent stem cells (iPSC-iNKT cells) and demonstrated the tolerability of this product in a previous phase 1 clinical trial. Although the iPSC-iNKT cells showed substantial anti-tumor activity against various tumor cell types when combined with α-Galactosylceramide-pulsed autologous dendritic cells (DC/Gal) in non-clinical experiments, the tolerability of this combination therapy for humans has not demonstrated yet. Thus, we planned this first-in-human phase 1 open-label clinical trial to demonstrate data on tolerability and safety, as well as explore the immunological changes that occur following this combination treatment. We hypothesize that the sequential induction of nasal submucosal DC/Gal injection and intra-arterial administration of the iPSC-iNKT cells is tolerable and has a favorable safety profile for cancer patients. This trial provides vital and fundamental information for next-phase clinical trials and future applications of iPSC-iNKT cells for various cancer patients (jRCTa030220741; URL: https://jrct.mhlw.go.jp/en-latest-detail/jRCTa030220741).

Indexed as

Dendritic CellsGalactosylceramidesHead and Neck NeoplasmsImmunotherapy, AdoptiveInduced Pluripotent Stem CellsNatural Killer T-CellsAdultClinical Trials, Phase I as TopicCombined Modality TherapyFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalTransplantation, Autologousalpha-galactosylceramideGalactosylceramides

Identifiers

PMID41746943
PMCPMC12944769

What Socratic 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 Socratic graph.