About this trial
Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.
Eligibility criteria
Qualifiers
Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the study
Adult males and females ≥18 years of age at screening
Life expectancy of at least 3 months
Histologically or cytologically confirmed unresectable advanced solid tumor (recurrent, metastatic, or locally advanced)
Disqualifiers
Ongoing toxicities ≥ Grade 2 per NCI CTCAE v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies)
NYHA Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG
QTcF >470 ms (females) or >450 ms (males)
Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
Trial design
Treatments tested in this trial
- SL-28
- SL-28
- SL-28