Evidence map›Paper›PMID 37729184›Full record

Trial reportPloS one2023

Integrated analysis of phase 1a and 1b randomized controlled trials; Treg-targeted cancer immunotherapy with the humanized anti-CCR4 antibody, KW-0761, for advanced solid tumors.

Kaoru Fujikawa, Takuro Saito, Koji Kurose, Takashi Kojima, Takeru Funakoshi, Eiichi Sato, Kazuhiro Kakimi, Shinsuke Iida, Yuichiro Doki, Mikio Oka and 2 more

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.3field-weighted citation impact, top 11% 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.

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

13 citing papers in PubMed, 14 citations in OpenAlex.

  1. Obesity Promotes Lung Carcinogenesis Through Airway Immune Dysfunction.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026
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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 at 8 institutions in 1 country.

Kaoru FujikawaDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Takuro SaitoDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.ORCID 0000-0002-1733-5064
Koji KuroseDepartment of Respiratory Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.ORCID 0000-0002-3878-1477
Takashi KojimaDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Takeru FunakoshiDepartment of Dermatology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.
Eiichi SatoDepartment of Pathology, Institute of Medical Science (Medical Research Center), Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.
Kazuhiro KakimiDepartment of Immunotherapeutics, The University of Tokyo Hospital, Bunkyo-Ku, Tokyo, Japan.ORCID 0000-0003-2631-3040
Shinsuke IidaDepartment of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Mikio OkaDepartment of Immuno-Oncology, Kawasaki Medical School, Kurashiki, Okayama, Japan.
Ryuzo UedaDepartment of Immunology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Hisashi WadaDepartment of Clinical Research in Tumor Immunology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.ORCID 0000-0002-5444-6193
The University of Osaka · JPKawasaki Medical School · JPKeio University · JPNagoya City University · JPNagoya University · JPNational Cancer Center Hospital East · JPTokyo Medical University · JPUniversity of Tokyo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRegulatory T cells (Tregs) have attracted attention as a novel therapeutic target to augment the clinical efficacy of immunotherapy. We conducted phase Ia and Ib trials to examine the safety and efficacy of the anti-CCR4 antibody, KW-0761 (mogamulizumab), which may eliminate effector Tregs (eTregs). We herein overviewed the results of these trials, presented cases with a durable clinical response, and investigated factors associated with the clinical effects of KW-0761.

methodsForty-nine patients with CCR4-negative solid cancers were enrolled in the phase Ia and Ib trials on KW-0761. An integral analysis of safety, clinical responses, prognosis, blood laboratory data, and cancer testis antigen-specific immune responses was performed.

resultsGrade 3-4 treatment-related adverse events were reported in 21 (42.9%) out of 49 patients, all of which were manageable. A partial response and stable disease were observed in 1 and 9 patients, respectively. A durable clinical response was noted in 2 esophageal and 2 lung cancer patients. eTreg depletion in peripheral blood was confirmed in most patients, and eTreg depletion was sustained during the KW-0761 treatment. High lymphocyte levels at baseline and 2 weeks after the initiation of KW-0761 were associated with a favorable clinical outcome.

conclusionsA durable clinical response was noted in some patients, and high lymphocyte levels before treatment initiation may be a biomarker for the efficacy of KW-0761. The synergistic effect of KW-0761 for depleting Tregs and other immunotherapies is expected in the future.

Indexed as

Lung NeoplasmsT-Lymphocytes, RegulatoryAntibodies, Monoclonal, HumanizedHumansImmunotherapyMaleAntibodies, Monoclonal, Humanizedmogamulizumab

Identifiers

PMID37729184
PMCPMC10511099
OpenAlexW4386884283

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.