Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2019
Phase I/II Trial of a Combination of Anti-CD3/CD7 Immunotoxins for Steroid-Refractory Acute Graft-versus-Host Disease.
Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
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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.
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.
Who cites it
21 citing papers in PubMed, 34 citations in OpenAlex.
- Advances in immunotoxin engineering: precision therapeutic strategies in modern oncology.Medical oncology (Northwood, London, England) · 2024Review
- New investigational drugs for steroid-refractory acute graft-versus-host disease: a review of the literature.Expert opinion on investigational drugs · 2024Review
- Recent advances in graft-versus-host disease.Faculty reviews · 2023Review
- Novel Pharmacological Treatment Options of Steroid-Refractory Graft-versus-Host Disease.Advances in hematology · 2023Review
- Synthesis of an Anti-CD7 Recombinant Immunotoxin Based on PE24 in CHO andInternational journal of molecular sciences · 2022Article
- Recent FDA Approvals in the Treatment of Graft-Versus-Host Disease.The oncologist · 2022Review
- Strategies to mitigate the on- and off-target toxicities of recombinant immunotoxins: an antibody engineering perspective.Antibody therapeutics · 2022Review
- The Role of Fecal Microbiota Transplantation in the Treatment of Acute Graft-versus-Host Disease.Biomedicines · 2022Review
- Natural Killer Cells in Hepatic Ischemia-Reperfusion Injury.Frontiers in immunology · 2022Review
- Steroid-Refractory Gut Graft-Versus-Host Disease: What We Have Learned From Basic Immunology and Experimental Mouse Model.Frontiers in immunology · 2022Review
- New therapeutic targets and biomarkers for acute graft-versus-host disease (GVHD).Expert opinion on therapeutic targets · 2021Review
- Current and Emerging Targeted Therapies for Acute Graft-Versus-Host Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Review
- GVHD Prophylaxis 2020.Frontiers in immunology · 2021Review
- Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody-Begelomab.Bone marrow transplantation · 2020Article
- Immunopathology and biology-based treatment of steroid-refractory graft-versus-host disease.Blood · 2020Review
- Development of Glypican-3 Targeting Immunotoxins for the Treatment of Liver Cancer: An Update.Biomolecules · 2020Review
- Review
- Engineering of Ribosome-inactivating Proteins for Improving Pharmacological Properties.Toxins · 2020Review
- Immunogenicity of Immunotoxins ContainingFrontiers in immunology · 2020Review
- Experimental Pharmaceuticals for Steroid-Refractory Acute Graft-versus-Host Disease.Journal of experimental pharmacology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 6 institutions in 3 countries.
Funding
Abstract
Effective therapies for treating patients with steroid-refractory acute graft-versus-host-disease (SR-aGVHD), particularly strategies that reduce the duration of immunosuppression following remission, are urgently needed. The investigated immunotoxin combination consists of a mixture of anti-CD3 and anti-CD7 antibodies separately conjugated to recombinant ricin A (CD3/CD7-IT), which induces in vivo depletion of T cells and natural killer (NK) cells and suppresses T cell receptor activation. We conducted a phase I/II trial to examine the safety and efficacy of CD3/CD7-IT in 20 patients with SR-aGVHD; 17 of these patients (85%) had severe SR-aGVHD, and all 20 patients had visceral organ involvement, including 18 (90%) with gastrointestinal (GI) involvement and 5 (25%) with liver involvement. A validated 2-biomarker algorithm classified the majority of patients (11 of 20) as high risk. On day 28 after the start of CD3/CD7-IT therapy, the overall response rate was 60% (12 of 20), with 10 patients (50%) achieving a complete response. The 6-month overall survival rate was 60% (12 of 20), including 64% (7 of 11) classified as high risk by biomarkers. The 1-week course of treatment with CD3/CD7-IT caused profound but transient depletion of T cells and NK cells, followed by rapid recovery of the immune system with a diverse TCR Vβ repertoire, and preservation of Epstein-Barr virus- and cytomegalovirus-specific T cell clones. Furthermore, our results indicate that CD3/CD7-IT appeared to be safe and well tolerated, with a relatively low prevalence of manageable and reversible adverse events, primarily worsening of hypoalbuminemia, microangiopathy, and thrombocytopenia. These encouraging results suggest that CD3/CD7-IT may improve patient outcomes in patients with SR-aGVHD.
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Registered trials
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.