Updated results from BNT211-01 (NCT04503278), an ongoing, first-in-human, phase I study evaluating safety and efficacy of CLDN6 CAR T cells and a CLDN6-encoding mRNA vaccine in patients with relapsed/refractory CLDN6+solid tumors

被引：2

作者：

Haanen, J. B. A. G. ^{[1
]}

Mackensen, A. ^{[2
]}

Schultze-Florey, C. ^{[3
]}

Alsdorf, W. ^{[4
]}

Wagner-Drouet, E. ^{[5
]}

Heudobler, D. ^{[6
]}

Borchmann, P. ^{[7
,8
]}

Busse, A. ^{[9
]}

Mielke, S. ^{[10
,11
]}

Bins, S. ^{[12
]}

Ungerechts, G. ^{[13
,14
]}

Bokemeyer, C. ^{[4
]}

Klobuch, S. ^{[1
]}

Kutsch, N. ^{[7
,8
]}

Mueller, F. ^{[2
]}

Desuki, A. ^{[5
]}

Zhong, W. ^{[15
]}

Preussner, L. ^{[16
]}

Tuereci, Oe. ^{[17
]}

Sahin, U. ^{[17
]}

机构：

[1] Netherlands Canc Inst, Div Med Oncol, Amsterdam, Netherlands

[2] Univ Hosp Erlangen, Dept Internal Med Hematol Oncol 5, Erlangen, Germany

[3] Hannover Med Sch, Dept Hematol Hemostasis Oncol & Stem Cell Transpl, Hannover, Germany

[4] Univ Med Ctr Hamburg Eppendorf, Div Pneumol, Dept Oncol Hematol & Bone Marrow Transplantat, Hamburg, Germany

[5] Univ Med Ctr Mainz, Dept Med 3, Hematol & Oncol, Mainz, Germany

[6] Univ Hosp Regensburg, Dept Internal Med Haematol & Oncol 3, Regensburg, Germany

[7] Univ Hosp Cologne, Dept Internal Med 1, Cologne, Germany

[8] Univ Hosp Cologne, Ctr Integrated Oncol Aachen Bonn Cologne Duesseld, Cologne, Germany

[9] Charite Univ Med Berlin, Dept Hematol Oncol & Tumor Immunol, Berlin, Germany

[10] Karolinska Inst, Dept Cell Therapy & Allogene Stem Cell Transplant, Dept Lab Med, Stockholm, Sweden

[11] Univ Hosp, Stockholm, Sweden

[12] Erasmus MC Canc Inst, Dept Med Oncol, Rotterdam, Netherlands

[13] Heidelberg Univ Hosp, Natl Ctr Tumor Dis NCT, Dept Med Oncol, Heidelberg, Germany

[14] German Canc Res Ctr, Heidelberg, Germany

[15] BioNTech US, Biostat, Cambridge, MA USA

[16] BioNTech Cell & Gene Therapies GmbH, BioNTech SE, Clin Dev, Mainz, Germany

[17] BioNTech Cell & Gene Therapies GmbH, BioNTech SE, Mainz, Germany

来源：

ANNALS OF ONCOLOGY | 2024年 / 35卷

关键词：

D O I：

10.1016/j.annonc.2024.08.678

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

611O

引用

页码：S489 / S490

页数：2

共 15 条

[1] BNT211-01: A phase I trial to evaluate safety and efficacy of CLDN6 CAR T cells and CLDN6-encoding mRNA vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumours
Mackensen, A.
Haanen, J. B. A. G.
Koenecke, C.
Alsdorf, W.
Wagner-Drouet, E.
Heudobler, D.
Borchmann, P.
Bokemeyer, C.
Klobuch, S.
Smit, E.
Mueller, F.
Desuki, A.
Lueke, F.
Wiegert, E.
Flemmig, C.
Schulz-Eying, C.
Rengstl, B.
Preussner, L.
Tuereci, Ö.
Sahin, U.
ANNALS OF ONCOLOGY, 2022, 33 (07) : S1404 - S1405
[2] CLDN6 CAR-T cell therapy of relapsed/refractory solid tumors ± a CLDN6-encoding mRNA vaccine: Dose escalation data from the BNT211-01 phase 1 trial using an automated product
Mackensen, Andreas
Haanen, John B. A. G.
Koenecke, Christian
Alsdorf, Winfried
Wagner-Drouet, Eva Maria
Heudobler, Daniel
Borchmann, Peter
Bokemeyer, Carsten
Klobuch, Sebastian
Kutsch, Nadine
Mueller, Fabian
Desuki, Alexander
Lueke, Florian
Wiegert, Erol
Flemmig, Carina
Schulz-Eying, Catrine
Rengstl, Benjamin
Preussner, Liane
Tuereci, Oezlem
Sahin, Ugur
JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 (16)
[3] BNT211-01: Interim results from a repeat dose escalation study of CLDN6 CAR-T cells manufactured with an automated process ± a CLDN6-encoding CAR-T cell-amplifying RNA Vaccine (CARVac)
Mackensen, A.
Haanen, J. B. A. G.
Alsdorf, W.
Koenecke, C.
Wagner-Drouet, E.
Borchmann, P.
Heudobler, D.
Busse, A.
Klobuch, S.
Kutsch, N.
Mueller, F.
Bokemeyer, C.
Desuki, A.
Lueke, F.
Ho, T.
Vemuri, K.
Preussner, L.
Rengstl, B.
Tuereci, O.
Sahin, U.
ANNALS OF ONCOLOGY, 2023, 34 : S1274 - S1275
[4] BNT211: A PHASE I TRIAL EVALUATING SAFETY AND EFFICACY OF CLDN6 CAR-T CELLS AND CARVAC-MEDIATED IN VIVO EXPANSION IN PATIENTS WITH CLDN6-POSITIVE ADVANCED SOLID TUMORS
Alsdorf, W.
Mackensen, A.
Haanen, J.
Koenecke, C.
Wagner-Drouet, E.
Heudobler, D.
Borchmann, P.
Bokemeyer, C.
Klobuch, S.
Smit, E.
Desuki, A.
Lueke, F.
Wiegert, E.
Schulz, C.
Rengstl, B.
Preussner, L.
Tuereci, O.
Sahin, U.
HUMAN GENE THERAPY, 2022, 33 (7-8) : A2 - A2
[5] CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial
Andreas Mackensen
John B.A.G. Haanen
Christian Koenecke
Winfried Alsdorf
Eva Wagner-Drouet
Peter Borchmann
Daniel Heudobler
Barbara Ferstl
Sebastian Klobuch
Carsten Bokemeyer
Alexander Desuki
Florian Lüke
Nadine Kutsch
Fabian Müller
Eveline Smit
Peter Hillemanns
Panagiotis Karagiannis
Erol Wiegert
Ying He
Thang Ho
Qing Kang-Fortner
Anna Melissa Schlitter
Catrine Schulz-Eying
Andrew Finlayson
Carina Flemmig
Klaus Kühlcke
Liane Preußner
Benjamin Rengstl
Özlem Türeci
Uğur Şahin
Nature Medicine, 2023, 29 : 2844 - 2853
[6] CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial
Mackensen, Andreas
Haanen, John B. A. G.
Koenecke, Christian
Alsdorf, Winfried
Wagner-Drouet, Eva
Borchmann, Peter
Heudobler, Daniel
Ferstl, Barbara
Klobuch, Sebastian
Bokemeyer, Carsten
Desuki, Alexander
Lueke, Florian
Kutsch, Nadine
Mueller, Fabian
Smit, Eveline
Hillemanns, Peter
Karagiannis, Panagiotis
Wiegert, Erol
He, Ying
Ho, Thang
Kang-Fortner, Qing
Schlitter, Anna Melissa
Schulz-Eying, Catrine
Finlayson, Andrew
Flemmig, Carina
Kuehlcke, Klaus
Preussner, Liane
Rengstl, Benjamin
Tuereci, Oezlem
Sahin, Ugur
NATURE MEDICINE, 2023, 29 (11) : 2844 - 2853
[7] BNT211: A PHASE I/II TRIAL TO EVALUATE SAFETY AND EFFICACY OF CLDN6 CAR-T CELLS AND VACCINE-MEDIATED IN VIVO EXPANSION IN PATIENTS WITH CLDN6-POSITIVE ADVANCED SOLID TUMORS
Mackensen, Andreas
Koenecke, Christian
Haanen, John
Alsdorf, Winfried
Desuki, Alexander
Wagner-Drouet, Eva
Heudobler, Daniel
Borchmann, Peter
Wiegert, Erol
Schulz, Catrine
Rengstl, Benjamin
Preussner, Liane
Tuereci, Oezlem
Sahin, Ugur
JOURNAL FOR IMMUNOTHERAPY OF CANCER, 2021, 9 : A1008 - A1008
[8] BNT211: a Phase 1 Study to determine the Safety and Efficacy of CLDN6 CAR T Cells and CARVAC-mediated in vivo Expansion in Patients with CLDN6-positive advanced solid Tumors
Haanen, J. B.
Mackensen, A.
Koenecke, C.
Alsdorf, W.
Wagner-Drouet, E.
Heudobler, D.
Borchmann, P.
Klobuch, S.
Smit, E.
Bokemeyer, C.
Desuki, A.
Luke, F.
Wiegert, E.
Schulz-Eying, C.
Rengstl, B.
Preussner, L.
Tureci, O.
Sahin, U.
ONCOLOGY RESEARCH AND TREATMENT, 2022, 45 (SUPPL 2) : 43 - 44
[9] BNT211: A Phase I trial to evaluate safety and efficacy of CLDN6 CAR-T cells and CARVac-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors
Haanen, John B. A. G.
Mackensen, Andreas
Koenecke, Christian
Alsdorf, Winfried
Wagner-Drouet, Eva
Heudobler, Daniel
Borchmann, Peter
Bokemeyer, Carsten
Klobuch, Sebastian
Desuki, Alexander
Lueke, Florian
Wiegert, Erol
Schulz, Catrine
Rengstl, Benjamin
Preussner, Liane
Tuereci, Oezlem
Sahin, Ugur
CANCER RESEARCH, 2022, 82 (12)
[10] BNT211: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and CARVac-mediated in vivo expansion in patients with CLDN6+advanced solid tumors
Haanen, J.
Mackensen, A.
Koenecke, C.
Alsdorf, W.
Desuki, A.
Wagner-Drouet, E.
Heudobler, D.
Borchmann, P.
Wiegert, E.
Schulz, C.
Rengstl, B.
Preussner, L.
Tuereci, O.
Sahin, U.
ANNALS OF ONCOLOGY, 2021, 32 : S1392 - S1392

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