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Head & Neck CancerPhase 1/2NCT07341737

SL-28 for Advanced Solid Tumours

A Phase 1/2 study testing SL-28 in people with Head & Neck Cancer and Pancreas Carcinoma, run by Second Life Therapeutics at 3 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SL-28
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesAustralia
Study dates
14 Aug 2026to 1 Mar 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 29Show fewer
  • 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

Who cannot join

  • 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:
Show all 19Show fewer
  • 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
  • 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
  • Receipt of live vaccines within 28 days prior to screening
  • Participation in another investigational study within 30 days prior to screening

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

George Tetz, MD, PhD contact

16466173088

clinical@secondlifetx.com

Australia3 sites, 3 recruiting
  • The Southern Oncology Clinical Research Unit (SOCRU)

    Adelaide, South Australia, 5042

    Ganessan Kichenadasse, ganessan.kichenadasse@socru.org.au

    Recruiting
  • John Flynn Private Hospital

    Gold Coast, Queensland, 4224

    David Martin, MD, 0755980964, dm.oncology@gmail.com

    Not yet recruiting
  • Liverpool Hospital

    Sydney, New South Wales, 3170

    Udit Nindra, Dr, +61287389744, Udit.Nindra@health.nsw.gov.au

    Not yet recruiting

Other trials in Australia

About this study

Official title: 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.

Read the detailed description

This study aims to assess the anti-tumour activity, safety, and interactions of single-agent SL-28 as an anti-cancer treatment in patients with a diverse array of solid tumours.

Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced solid tumor, including head and neck cancer, small-cell lung cancer, non-small cell lung cancer; mesothelioma; oesophageal cancer, gastric cancer, liver cancer, colorectal cancer, pancreatic cancer, bladder cancer, kidney cancer, prostate cancer, ovarian cancer, endometrial cancer, breast cancer or skin cancer (melanoma) that is locally advanced, metastatic or unable to be surgically removed. Patients will also be assessed by a study doctor to ensure that they are well enough to participate in the trial before they will be offered enrolment into the study.

Study details All participants who choose to enroll in this study will receive 12 weeks of SL-28 treatment, administered on a 5-days-on, 2-days-off schedule. The first group of participants to receive SL-28 will be monitored for 12 weeks before a second group may be administered a higher dose of SL-28. Up to three cohorts will be enrolled to determine the highest safe and effective dose that does not cause severe side effects in patients.

It is hoped this study will show that SL-28 is safe to deliver to patients with solid tumour cancers, and determine the highest dose of SL-28 that cancer patients can safely receive.

Being tested
SL-28
Medical subject headings
Head and Neck Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Adenocarcinoma of Lung, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SL-28Biological

    Doses administered: 3×10^7 cells/injection, once daily, 5 days per week, 12 weeks.

    Mode of administration: intravenous push

  • SL-28Biological

    Doses administered: 6×10^7 cells/injection, once daily, 5 days per week, 12 weeks.

    Mode of administration: intravenous push

  • SL-28Biological

    Doses administered: to-be-determeined-later Mode of administration: intravenous push

Study groups in NCT07341737
Study groupRoleWhat they receive
SL-28 Low DoseExperimentalNot described
Receives: Biological: SL-28
SL-28 Intermediate DoseExperimentalNot described
Receives: Biological: SL-28
SL-28 High DoseExperimentalNot described
Receives: Biological: SL-28

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

  6. Change from baseline in vital signs

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

    Measured: 12 weeks

  7. Number of participants with dose-limiting toxicities (DLTs)

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

    Measured: 12 weeks

Secondary outcomes (3)
  1. Objective Response Rate (ORR) per RECIST 1.1

    Objective response rate will be defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by CT or MRI imaging.

    Measured: 12 weeks

  2. Objective Response Rate (ORR) per iRECIST

    Objective Response Rate (ORR) per iRECIST

    Measured: 12 weeks

  3. Disease Control Rate (DCR) per RECIST 1.1

    Disease control rate will be defined as the proportion of participants achieving CR, PR, or stable disease (SD) according to RECIST version 1.1.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start14 Aug 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07341737
Sponsor's protocol ID
SL-28-FIH
Status last verified
Sep 2026
First submitted
17 Nov 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41347084
  • 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.

    PubMed 41185720
  • 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.

    PubMed 36195904
  • 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.

    PubMed 39896476
  • 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.

    PubMed 39754239
  • 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.

    PubMed 40578310

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SL-28 in people with Head & Neck Cancer and Pancreas Carcinoma, run by Second Life Therapeutics at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact George Tetz, MD, PhD (16466173088, clinical@secondlifetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse events (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07341737, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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