SL-28 for Advanced Solid Tumours

NCT07341737 | Not Yet Recruiting Phase 1

• 1 other identifier: SL-28-FIH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head & Neck Cancer; Pancreas Carcinoma; Pancreas Cancer, Metastatic; Lung Adenocarcinoma; Lung Cancer (NSCLC); Lung Cancer (Non-Small Cell); Esophageal Cancer; Stomach (Gastric) Cancer; Liver Cancer; Intestinal Cancer; Bladder Cancer; Renal Cancer; Prostate Cancer; Melanoma (Skin Cancer); Breast Cancer; Ovarian Cancer; Endometrial Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (7)

• Number of participants with treatment-emergent adverse events

  Treatment-emergent adverse events will be assessed and graded by the investigator according to the CTCAE v5

  12 weeks

• To evaluate the safety and tolerability of SL-28 by determining the incidence of dose-limiting toxicitieswithin the first 28 days after infusion.

  Assessment of dose limiting toxicities assessed by the occurrence of treatment-emergent adverse events(TEAEs) graded by the Investigator per the National Cancer Institute Common Terminology Criteria forAdverse Events, version 5.0.

  12 weeks

• Change from baseline in ECG QT interval

  Electrocardiograms will be recorded using a 12-lead ECG machine, and the QT interval (milliseconds) will be evaluated and summarized as change from baseline.

  12 weeks

• Change from baseline in vital signs

  Vital signs including systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)will be measured using standard clinical equipment and summarized as change from baseline.

  12 weeks

• Change from baseline in vital signs

  Vital signs: Heart rate (beats per minute) will be measured using standard clinical equipment and summarized as change from baseline.

  12 weeks

• Change from baseline in vital signs

  Vital signs: body temperature (°C) will be measured using standard clinical equipment and summarized as change from baseline.

  12 weeks

• Number of participants with dose-limiting toxicities (DLTs)

  Dose-limiting toxicities will be assessed during the DLT evaluation period as defined in the protocol.

  12 weeks

Secondary Outcomes (3)

• Objective Response Rate (ORR) per RECIST 1.1

  12 weeks

• Objective Response Rate (ORR) per iRECIST

  12 weeks

• Disease Control Rate (DCR) per RECIST 1.1

  12 weeks

Study Arms (3)

SL-28 Low Dose

EXPERIMENTAL

Biological: SL-28

SL-28 Intermediate Dose

EXPERIMENTAL

Biological: SL-28

SL-28 High Dose

EXPERIMENTAL

Biological: SL-28

Interventions

SL-28 BIOLOGICAL

Doses administered: 3×10\^7 cells/injection, once daily, 5 days per week, 12 weeks. Mode of administration: intravenous push

SL-28 Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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
• 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
• Nitrosoureas or mitomycin C within 6 weeks
• Concurrent malignancy within 5 years, except specified low-risk cancers
• Pregnancy or breastfeeding
• Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection
• Inability or unwillingness to comply with protocol procedures
• History of anaphylaxis or significant allergy interfering with participation

Sponsors & Collaborators

• Second Life Therapeutics: lead

Study Sites (1)

Hollywood Private Hospital

Nedlands, Western Australia, Australia

Location

Related Publications (6)

• Tetz V, Kardava K, Shulenbayev O, Vecherkovskaya M, Khodadadi-Jamayran A, Tsirigos A, Tetz G. Partial response in a patient with skeletal and hepatic metastases following resected pancreatic cancer to the novel cell therapy SL-28: a case report. Front Oncol. 2025 Nov 19;15:1636989. doi: 10.3389/fonc.2025.1636989. eCollection 2025.

  PMID: 41347084 BACKGROUND

• Tetz V, Kardava K, Shulenbayev O, Vecherkovskaya M, Khodadadi-Jamayran A, Tsirigos A, Tetz G. Dramatic Clinical Response to a Novel Form of Cell Therapy SL-28 in a Patient with Prostate Cancer and Bone Metastasis: A Case Report. Immunotargets Ther. 2025 Oct 29;14:1201-1207. doi: 10.2147/ITT.S547989. eCollection 2025.

  PMID: 41185720 BACKGROUND

• Tetz V, Tetz G. Novel prokaryotic system employing previously unknown nucleic acids-based receptors. Microb Cell Fact. 2022 Oct 4;21(1):202. doi: 10.1186/s12934-022-01923-0.

  PMID: 36195904 BACKGROUND

• Tetz V, Kardava K, Vecherkovskaya M, Khodadadi-Jamayran A, Tsirigos A, Tetz G. Regulating white blood cell activity through the novel Universal Receptive System. bioRxiv [Preprint]. 2025 Jan 20:2025.01.06.631232. doi: 10.1101/2025.01.06.631232.

  PMID: 39896476 BACKGROUND

• Tetz G, Kardava K, Vecherkovskaya M, Khodadadi-Jamayran A, Tsirigos A, Tetz V. Universal receptive system as a novel regulator of transcriptomic activity of Staphylococcus aureus. Microb Cell Fact. 2025 Jan 3;24(1):1. doi: 10.1186/s12934-024-02637-1.

  PMID: 39754239 BACKGROUND

• Tetz V, Kardava K, Vecherkovskaya M, Khodadadi-Jamayran A, Tsirigos A, Tetz G. The universal receptive system: a novel regulator of antimicrobial and anticancer compound production by white blood cells. J Leukoc Biol. 2025 Jun 4;117(6):qiaf085. doi: 10.1093/jleuko/qiaf085.

  PMID: 40578310 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Pancreatic Neoplasms; Neoplasm Metastasis; Adenocarcinoma of Lung; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Stomach Neoplasms; Liver Neoplasms; Intestinal Neoplasms; Urinary Bladder Neoplasms; Kidney Neoplasms; Prostatic Neoplasms; Melanoma; Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Gastrointestinal Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Liver Diseases; Intestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Kidney Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Colonic Diseases; Rectal Diseases

Central Study Contacts

George Tetz, MD, PhD

CONTACT

16466173088; clinical@secondlifetx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1/2 open-label study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of SL-28, an allogeneic, non human leukocyte antigen (HLA)-matched, modified T -cell-based treatment for advanced and unresectable solid tumours. The study will be conducted in 4 parts: * Part 1: Phase 1a dose escalation as a 3+3 design, with a single dose on Day 1 followed by daily dosing from Day 8 * Part 2: Phase 1b dose expansion at the maximum tolerated dose (MTD) * Part 3: Phase 2a dose expansion in 3 tumour types * Part 4: Phase 2a dose expansion in the tumour type showing the highest efficacy to SL-28

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 14, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)