Tests SL-28 cell therapy in adults with advanced solid tumours

Trial details

Who runs it

Second Life Therapeutics

Trial code

NCT07341737

Record updated

15 September 2026

Original description

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.Read full original descriptionShow less

A Phase 1/2, Multicentre, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of SL-28 in Patients With Advanced Solid Tumours

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.

Inclusion: 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); Disease refractory to, intolerant of, or refusal of standard therapies, including immunotherapy and molecular/biomarker-directed treatments, as determined by the Principal Investigator (PI) or delegate; Eligible tumor types include:; Head and neck squamous cell carcinoma; Thoracic malignancies (small-cell lung cancer, non-small cell lung cancer, esophageal cancer); Gastrointestinal malignancies (gastric, liver, colorectal, pancreatic adenocarcinoma); Genitourinary malignancies (bladder, renal cell, prostate cancer); Gynecologic malignancies (ovarian, endometrial cancer); Breast cancer and melanoma; Evaluable disease per RECIST v1.1; ECOG performance status 0-1 (or up to 2 at PI discretion); Adequate organ function, defined as:; Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for liver metastases or Gilbert's syndrome); AST, ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion); Creatinine clearance ≥50 mL/min (Cockcroft-Gault) or eGFR ≥50 mL/min (CKD-EPI); Absolute neutrophil count ≥1,000/mm³; Platelet count ≥100,000/mm³; Hemoglobin ≥90 g/L without transfusion within 2 weeks; Prothrombin time and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation); Female patients:; -Non-childbearing potential (surgically sterile or postmenopausal), or of childbearing potential with negative pregnancy tests and agreement to effective contraception through 90 days post-dose; Male patients:; Agreement not to donate sperm for 90 days post-dose; Agreement to use adequate contraception as applicable; Suitable venous access for blood sampling; Willingness and ability to comply with study procedures and protocol requirements.

Exclusion: Requirement for systemic corticosteroids or other immunosuppressive therapy that cannot be discontinued ≥14 days prior to dosing; Prior therapies within restricted timeframes:; Immune checkpoint inhibitors or biologics within 28 days; Antineoplastic therapies, surgery, radiotherapy, or radiopharmaceuticals within 21 days; Unapproved investigational drugs within 5 half-lives; Concurrent malignancy within 5 years, except specified low-risk cancers; Receipt of live vaccines within 28 days prior to screening; Participation in another investigational study within 30 days prior to screening; NYHA Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG; Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy; Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection; History of anaphylaxis or significant allergy interfering with participation; Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, neurologic, psychiatric, or immunologic disease within 6 months; Conditions affecting drug absorption, distribution, metabolism, or excretion; Ongoing toxicities ≥ Grade 2 per NCI CTCAE v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies); QTcF >470 ms (females) or >450 ms (males); Nitrosoureas or mitomycin C within 6 weeks; Pregnancy or breastfeeding; Inability or unwillingness to comply with protocol procedures.

ClinicalTrials.gov NCT07341737