On October 13, 2014 Dynavax Technologies reported the initiation of a phase 1/2 clinical trial to assess the safety and preliminary efficacy of SD-101, an investigational Toll-like receptor ("TLR") 9 agonist, in adults with untreated low-grade B-cell lymphoma (Press release Dynavax Technologies, OCT 13, 2014, View Source [SID:1234500825]). In this multicenter study (known as LYM-01), SD-101 is administered intratumorally in combination with localized low-dose radiation. The open-label, dose escalation and expansion design of LYM-01 is intended to accelerate dose optimization while simultaneously assessing the safety, tolerability and initial local and distant antitumor activity of SD-101.
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"Beginning LYM-01 is an important milestone in the maturation of Dynavax’s TLR-based cancer immunotherapy research and development efforts" said Eddie Gray, Dynavax CEO. "This study will provide a range of data that will be integral to our strategy for evaluating SD-101 both alone and in combination with other immuno-oncology agents, such as checkpoint inhibitors."
LYM-01 Study Design
LYM-01 is an open-label, single arm, multicenter, dose-escalation and expansion study designed to evaluate the safety and preliminary efficacy of localized low-dose radiation therapy and intratumoral SD-101 injection into a single target lesion. It will include up to 25 patients diagnosed with untreated low-grade B-cell lymphomas who do not require immediate systemic therapy and are appropriate candidates for "watch and wait." Treatment consists of local radiation given over 2 days followed by 5 weekly intratumoral injections of 1, 2, 4, or 8 mg of SD-101. The total duration of patient participation in this study is up to 2 years.
The primary objectives of LYM-01 are:
To assess safety and tolerability of escalating doses of SD-101 administered with low-dose radiation;
To evaluate the pharmacodynamic profile of interferon-inducible genes in whole blood 24 hours after injection; and
To determine the maximum tolerated dose or optimal dose.
A key secondary objective of the study is assessment of the objective response to SD-101 in untreated lesions distant from the lesion in which SD-101 and radiation were administered. All tumor responses are assessed according to the Cheson criteria.