Treatment of Refractory Hodgkin's Disease With an Anti-CD16/CD30 Bispecific Antibody
Abstract
Fifteen patients with refractory Hodgkin's disease were treated in a phase I/II trial with the natural killer (NK)-cell–activating bispecific monoclonal antibody HRS-3/A9, which is directed against the Fcγ-receptor III (CD16 antigen) and the Hodgkin's-associated CD30 antigen, respectively. Median counts of NK cells and of all lymphocyte subsets were considerably decreased in the patients before therapy. HRS-3/A9 was administered 4 times every 3 to 4 days, starting with 1 mg/m2. The treatment was well tolerated, and the maximum tolerated dose was not reached at 64 mg/m2, the highest dose administered because of the limited amounts of HRS-3/A9 available. Side effects were rare and consisted of fever, pain in involved lymph nodes, and a maculopapulous rash. A total of 9 patients developed human antimouse Ig antibodies, and 4 patients developed an allergic reaction after attempted retreatment. A total of 1 complete and 1 partial remission (lasting 16 and 3 months, respectively), 3 minor responses (1 to 11+ months), and 1 mixed response were achieved. There was no clear-cut dose-side effect or dose-response correlation. Our results encourage further clinical trials with this novel immunotherapeutic approach and emphasize the necessity to reduce the immunogenicity of the murine bispecific antibodies.
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Two Phase 1 clinical studies of HRS-3/A9 led to one complete remission and one partial remission in 15 treated patients; a second trial led to one complete remission and three partial remissions.
“Two Phase 1 clinical studies performed with this molecule led to one complete remission (CR) and one partial remission (PR) in a group of 15 treated patients; 14 this was followed by one CR and three PR in a second clinical trial. 15”
From Bispecific antibodies for cancer therapy: The light at the end of the tunnel? (2009) · cites this paper as [14]
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- Authors
- Hartmann, F., Renner, C., Jung, W., Deisting, C., Juwana, M., Eichentopf, B., Kloft, M., & Pfreundschuh, M.
- Affiliations
- Universitätsklinikum des Saarlandes (DE)
- Venue
- Blood
- Publisher
- American Society of Hematology
- Published
- 1997-03-15
- Volume
- 89
- Issue
- 6
- Pages
- 2042-2047
- ISSN
- 0006-4971 (ISSN-L)
- 1528-0020
- OpenAlex
- W1539079695
- Cited by
- 149
- References
- 29
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 4 · 2023: 3 · 2022: 4 · 2021: 4 · 2020: 3 · 2019: 3 · 2018: 5 · 2017: 4 · 2016: 8 · 2015: 5 · 2014: 5 · 2013: 6 · 2012: 7
- FWCI
- 5.83
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Blood (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Life Sciences › Immunology and Microbiology › Immunology › Immune Cell Function and Interaction
- Keywords
- refractory Hodgkin lymphoma, bispecific antibodies, CD16, CD30, NK cell activation, Fc gamma receptor III, immunotherapy, maximum tolerated dose, human anti-mouse antibodies, immunogenicity, allergic reactions, treatment response
- MeSH terms
- Adolescent, Adult, Antibodies, Monoclonal, Female, Hodgkin Disease, Humans, Male, Middle Aged, Remission Induction, Lymphocyte Subsets, Receptors, IgG, Ki-1 Antigen, Antibodies, Bispecific, Lymphocyte Count
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