Starton Therapeutics has entered a clinical trial agreement with the Stanford School of Medicine to assess its STAR-LLD candidate alongside a new chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma (MM).
The upcoming investigator-initiated trial will enrol participants diagnosed with relapsed or refractory (r/r) MM. It intends to evaluate the safety profile and early efficacy signals of the combined regimen.
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The study also plans to measure correlative biomarkers to map immune responses across varied dosage levels and verify pharmacokinetic and pharmacodynamic relationships.
Researchers will specifically examine whether the combination enhances therapeutic outcomes when administered alongside cellular immunotherapies.
Stanford Medicine will hold sole responsibility for designing the clinical protocol and conducting the trial.
Starton Therapeutics plans to utilise the resulting findings to underpin an investigational new drug application for a Phase II trial combining STAR-LLD with B-cell maturation antigen (BCMA) CAR-T therapies in MM.
Starton Therapeutics chairman and CEO Pedro Lichtinger said: “We are excited to collaborate with Stanford Medicine and advance the evaluation of STAR-LLD.
“This agreement represents an important step in our strategy, as we believe this combination has the potential to improve CAR-T cell expansion and persistence, while minimising the known toxicity of immunomodulatory imide drugs (IMiD).”
STAR-LLD is a continuous delivery lenalidomide (LLD) under development for chronic lymphocytic leukaemia and MM.
Prior Phase Ib clinical testing in six individuals with r/r MM yielded objective responses across all participants, comprising one complete response and five partial responses.
Over treatment courses lasting up to 12 cycles, no subjects experienced treatment-related anaemia, leukopenia, neutropenia, or thrombocytopenia exceeding grade 2.
Starton Therapeutics develops continuous-delivery systems designed to adapt approved cancer therapies, improve their tolerability, and widen their therapeutic applications.
In September 2024, the company successfully demonstrated the use of BD’s on-body injector technology to deliver STAR-LLD.
