Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients
Vinu Chandralayam Ayyappa Menon, Tomomi Matsuura, Beata Holkova, Girish S. Gudi, Adam Drake, Maria Pihlgren, Piet H. van der Graaf, Sunitha GN, Andrew Garton, Mario Perro, Cyril Konto, Lida Pacaud · 2026
Read Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients by Vinu Chandralayam Ayyappa Menon, Tomomi Matsuura, Beata Holkova, Girish S. Gudi, Adam Drake, Maria Pihlgren, Piet H. van der Graaf, Sunitha GN, Andrew Garton, Mario Perro, Cyril Konto, Lida Pacaud (2026) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-13339390.txt.
Description
Vinu Chandralayam Ayyappa Menon and colleagues described preclinical dose work in 2026 for ISB 2001, a trispecific antibody for relapsed multiple myeloma. The antibody binds CD38 and BCMA on tumour cells and links to CD3 on T cells, directing T cells to kill myeloma cells. It is now in a first in human trial, TRIgnite-1, yet its CD3 binding part does not react with monkey CD3.
Without a fully reactive animal species, standard pharmacokinetic and toxicology data could not guide the first human dose directly. The paper lays out the alternative modelling used to predict a safe starting dose. The approach matters for complex antibodies where animal models fall short of human biology.
Catalog record
| CREATOR | Vinu Chandralayam Ayyappa Menon, Tomomi Matsuura, Beata Holkova, Girish S. Gudi, Adam Drake, Maria Pihlgren, Piet H. van der Graaf, Sunitha GN, Andrew Garton, Mario Perro, Cyril Konto, Lida Pacaud |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 42 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |