Evidence map›Paper›PMID 32948652›Full record

Trial reportJournal for immunotherapy of cancer2020

Adoptive transfer of zoledronate-expanded autologous Vγ9Vδ2 T-cells in patients with treatment-refractory non-small-cell lung cancer: a multicenter, open-label, single-arm, phase 2 study.

Kazuhiro Kakimi, Hirokazu Matsushita, Keita Masuzawa, Takahiro Karasaki, Yukari Kobayashi, Koji Nagaoka, Akihiro Hosoi, Shinnosuke Ikemura, Kentaro Kitano, Ichiro Kawada and 10 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed
1.6field-weighted citation impact, top 14% 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

34 citing papers in PubMed, 40 citations in OpenAlex.

  1. γδ T cells and cancer.The Journal of clinical investigation · 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

20 authors at 5 institutions in 1 country.

Kazuhiro KakimiDepartment of Immunotherapeutics, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan kakimi@m.u-tokyo.ac.jp ksoejima@cpnet.med.keio.ac.jp NAKAJIMA-THO@h.u-tokyo.ac.jp.ORCID 0000-0003-2631-3040
Hirokazu MatsushitaDepartment of Immunotherapeutics, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.ORCID 0000-0001-9069-7160
Keita MasuzawaDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine Graduate School of Medicine, Shinjuku-ku, Tokyo, Japan.
Takahiro KarasakiDepartment of Immunotherapeutics, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.
Yukari KobayashiDepartment of Immunotherapeutics, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.
Koji NagaokaDepartment of Immunotherapeutics, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.
Akihiro HosoiDepartment of Immunotherapeutics, The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.
Shinnosuke IkemuraDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine Graduate School of Medicine, Shinjuku-ku, Tokyo, Japan.
Kentaro KitanoDepartment of Thoracic Surgery, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Ichiro KawadaDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine Graduate School of Medicine, Shinjuku-ku, Tokyo, Japan.
Tadashi ManabeDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine Graduate School of Medicine, Shinjuku-ku, Tokyo, Japan.
Tomohiro TakeharaDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine Graduate School of Medicine, Shinjuku-ku, Tokyo, Japan.
Toshiaki EbisudaniDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine Graduate School of Medicine, Shinjuku-ku, Tokyo, Japan.
Kazuhiro NagayamaDepartment of Thoracic Surgery, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Yukio NakamuraRepertoire Genesis Inc, Ibaraki-Shi, Osaka, Japan.
Ryuji SuzukiRepertoire Genesis Inc, Ibaraki-Shi, Osaka, Japan.
Hiroyuki YasudaDivision of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine Graduate School of Medicine, Shinjuku-ku, Tokyo, Japan.
Masaaki SatoDepartment of Thoracic Surgery, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Kenzo SoejimaClinical and Translational Research Center, Keio University Hospital, Shinjuku-ku, Tokyo, Japan kakimi@m.u-tokyo.ac.jp ksoejima@cpnet.med.keio.ac.jp NAKAJIMA-THO@h.u-tokyo.ac.jp.
Jun NakajimaDepartment of Thoracic Surgery, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan kakimi@m.u-tokyo.ac.jp ksoejima@cpnet.med.keio.ac.jp NAKAJIMA-THO@h.u-tokyo.ac.jp.
Keio University · JPUniversity of Tokyo Hospital · JPThe University of Tokyo · JPGenesis Research Institute · JPKeio University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNot all non-small cell lung cancer (NSCLC) patients possess drug-targetable driver mutations, and response rates to immune checkpoint blockade therapies also remain unsatisfactory. Therefore, more effective treatments are still needed. Here, we report the results of a phase 2 clinical trial of adoptive cell therapy using zoledronate-expanded autologous Vγ9Vδ2 T-cells for treatment-refractory NSCLC.

methodsNSCLC patients who had undergone at least two regimens of standard chemotherapy for unresectable disease or had had at least one treatment including chemotherapy or radiation for recurrent disease after surgery were enrolled in this open-label, single-arm, multicenter, phase 2 study. After preliminary testing of Vγ9Vδ2 T-cell proliferation, autologous peripheral blood mononuclear cells were cultured with zoledronate and IL-2 to expand the Vγ9Vδ2 T-cells. Cultured cells (>1×10

resultsTwenty-five patients (20 adenocarcinoma, 4 squamous cell carcinoma and 1 large cell carcinoma) were enrolled. Autologous Vγ9Vδ2 T-cell therapy was administered to all 25 patients, of which 16 completed the foreseen course of 6 injections of cultured cells. Median PFS was 95.0 days (95% CI 73.0 to 132.0 days); median OS was 418.0 days (179.0-479.0 days), and best overall responses were 1 partial response, 16 stable disease (SD) and 8 progressive disease. ORR and DCR were 4.0% (0.1%-20.4%) and 68.0% (46.5%-85.1%), respectively. Severe adverse events developed in nine patients, mostly associated with disease progression. In one patient, pneumonitis and inflammatory responses resulted from Vγ9Vδ2 T-cell infusions, together with the disappearance of a massive tumor.

conclusionsAlthough autologous Vγ9Vδ2 T-cell therapy was well tolerated and may have an acceptable DCR, this trial did not meet its primary efficacy endpoint. TRIAL REGISTRATION NUMBER: UMIN000006128.

Indexed as

AdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedReceptors, Antigen, T-Cell, gamma-deltaZoledronic AcidReceptors, Antigen, T-Cell, gamma-deltaZoledronic Acidadoptivecellularimmunityimmunotherapylung neoplasms

Identifiers

PMID32948652
PMCPMC7511646
OpenAlexW3087659785

What OpenQuestion holds

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Registered trials

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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.