Evidence map›Paper›PMID 40746940›Full record

Trial reportBlood neoplasia2025

Dose escalation study of the HLA-A2-WT1 CD3 bispecific antibody RO7283420 in relapsed/refractory acute myeloid leukemia.

Martin Hutchings, Koorosh Korfi, Pau Montesinos, Armando Santoro, Hsin-An Hou, Pilar Martinez-Sanchez, Susana Vives, Sara Galimberti, Tsai-Yun Chen, Marco Frigeni and 23 more

Abstract readClinical Trial
In one paragraph

Trial report in Blood neoplasia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–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

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. 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

33 authors.

Martin HutchingsDepartment of Hematology and Phase 1 Unit, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Koorosh KorfiRoche Pharma Research and Early Development, Oncology, Roche Innovation Center Zurich, Schlieren, Switzerland.
Pau MontesinosDepartment of Hematology, University Hospital of La Fe in Valencia, Valencia, Spain.
Armando SantoroDepartment of Biomedical Sciences, Humanitas University, Milan, Italy.
Hsin-An HouDivision of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
Pilar Martinez-SanchezDepartment of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Susana VivesDepartament de Medicina, Hospital Universitario Germans Trias i Pujol-Institut Català d'Oncologia Badalona, Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Badalona, Spain.
Sara GalimbertiDepartment of Clinical and Experimental Medicine, Section of Hematology, University of Pisa, Pisa, Italy.
Tsai-Yun ChenDivision of Hematology-Oncology, National Cheng Kung University Hospital, Tainan, Taiwan.
Marco FrigeniDepartment of Oncology and Hematology, Azienda Sociosanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Sylvain GarciazDepartment of Hematology, Aix-Marseille University, INSERM, Centre national de la recherche scientifique, Institut Paoli-Calmettes, Centre de Recherche en Cancérologie de Marseille, Marseille, France.
Olga Salamero GarciaDepartment of Hematology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Su-Peng YehDepartment of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Karen YeeCancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, ON, Canada.
Jordi EsteveDepartment of Hematology, Hospital Clinic de Barcelona, Barcelona, Spain.
Ashish BajelDepartment of Clinical Haematology, Peter MacCallum Cancer Centre and The Royal Melbourne Hospital, Melbourne, VIC, Australia.
Shaun FlemingDepartment of Hematology, The Alfred Hospital and Australian Centre for Blood Diseases, Monash University, Melbourne, Australia.
Anne Catherine BretzRoche Pharma Research and Early Development, Oncology, Roche Innovation Center Munich, Penzberg, Germany.
Jan AttigRoche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
Min SunRoche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
Sina NassiriRoche Pharma Research and Early Development, Oncology, Roche Innovation Center, Basel, Switzerland.
Tobias RutishauserRoche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
Christian KleinRoche Pharma Research and Early Development, Oncology, Roche Innovation Center Zurich, Schlieren, Switzerland.
Y May MaRoche Pharma Research and Early Development, Oncology, Roche Innovation Center, Basel, Switzerland.
Gabriel SchnetzlerRoche Pharma Research and Early Development, Oncology, Roche Innovation Center, Basel, Switzerland.
Stephanie VauleonRoche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
Huixin YuRoche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
Teresa BarataRoche Product Development, Data Science, Roche Innovation Center, Basel, Switzerland.
Muriel RichardRoche Pharma Research and Early Development, Oncology, Roche Innovation Center Zurich, Schlieren, Switzerland.
Silke SimonRoche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland.
Heather HintonProduct Development Safety, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Nino KeshelavaRoche Pharma Research and Early Development, Oncology, Roche Innovation Center Zurich, Schlieren, Switzerland.
Marion SubkleweDepartment of Medicine III, University Hospital, Ludwig Maximilian University Munich, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A novel T-cell bispecific antibody (TCB), RO7283420, engaging CD3 and the HLA-A2-Wilms tumor protein 1 complex, was evaluated in this phase 1 study to characterize safety and tolerability, determine the maximum tolerated dose (MTD), and recommend a phase 2 dose for patients with relapsed/refractory acute myeloid leukemia in 2 groups: hematologic (group I, n = 57) and molecular (group 2, n = 5) relapse. In group I, 51 received RO7283420 intravenously (IV) and 6 subcutaneously. The IV doses ranged from 0.15-4 mg (flat; n = 13), 3-18 mg (step-up; n = 34) every 3 weeks, or 9 mg weekly (step-up; n = 4). The MTD was 1/3/12 mg every 3 weeks. The most frequent adverse event in the overall population was cytokine release syndrome (61.3%) with grade ≥3 recorded in 9.7% of patients. Twelve dose-limiting toxicities were reported in 11 patients and 12 (19.4%) grade 5 adverse events, including 1 hemophagocytic lymphohistiocytosis case related to RO7283420. Among the 42 efficacy-evaluable IV patients in group I, 4.8% achieved complete remission (CR), and 2.4% achieved CR with incomplete hematologic recovery. RO7283420 induced pharmacodynamic changes in peripheral blood (PB) at doses ≥1 mg, including significant T-cell activation and expansion in the PB and bone marrow (BM). Significant associations were found between blast reduction and baseline immunophenotype, including lower regulatory T cells and higher non-exhausted CD8

Identifiers

PMID40746940
PMCPMC12311517

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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.