ClinicalTrials.gg
RecruitingNCT07341737Updated Sep 15, 2026

SL-28 for Advanced Solid Tumours

A Phase 1/2 interventional study of SL-28 and SL-28 in Head & Neck Cancer, Pancreas Carcinoma and Pancreas Cancer, Metastatic, sponsored by Second Life Therapeutics. Recruiting at 3 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Primary conditionEsophageal NeoplasmsRegistry: Head and Neck NeoplasmsReclassifiedWhy we changed it
Registry
Head and Neck Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Esophageal Neoplasms
Why
  1. The study's listed conditions name Esophageal Neoplasms, a narrower term within Head and Neck Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Second Life Therapeutics · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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
03

In context

Esophageal Neoplasms Reclassified

1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.

This study's planned enrollment of 60 is close to the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Second Life Therapeutics is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Compared within Esophageal Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Head and Neck Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to provide written 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
  • of at least 3 months
  • or cytologically confirmed unresectable advanced solid tumor (recurrent, , or locally advanced)
  • Disease 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 (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 v1.1
  • performance status 0-1 (or up to 2 at PI discretion)
  • Adequate organ function, defined as:
  • Total ≤1.5 × (≤2.0 × ULN for liver metastases or Gilbert's syndrome)
  • , ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion)
  • ≥50 mL/min (Cockcroft-Gault) or ≥50 mL/min (CKD-EPI)
  • ≥1,000/mm³
  • count ≥100,000/mm³
  • ≥90 g/L without transfusion within 2 weeks
  • and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation)

Female patients:

-Non- (surgically sterile or ), or of childbearing potential with negative pregnancy tests and agreement to effective 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 criteria

Exclusion Criteria:

  • Ongoing toxicities ≥ Grade 2 per v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies)
  • Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on
  • >470 ms (females) or >450 ms (males)
  • Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
  • Requirement for systemic or other therapy that cannot be discontinued ≥14 days prior to dosing
  • Prior therapies within restricted timeframes:
  • or biologics within 28 days
  • Antineoplastic therapies, surgery, radiotherapy, or radiopharmaceuticals within 21 days
  • Unapproved drugs within 5 half-lives
  • Nitrosoureas or mitomycin C within 6 weeks
  • Concurrent within 5 years, except specified low-risk cancers
  • Pregnancy or breastfeeding
  • Known , (HBsAg positive), or infection
  • Inability or unwillingness to comply with protocol procedures
  • History of anaphylaxis or significant allergy interfering with participation
  • 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 within 28 days prior to screening
  • Participation in another investigational study within 30 days prior to screening
Terms in these criteria, in plain language(33)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    SL-28 Low Dose

    Biological: SL-28

  • Experimental
    SL-28 Intermediate Dose

    Biological: SL-28

  • Experimental
    SL-28 High Dose

    Biological: SL-28

Interventions

  • BiologicalSL-28

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

  • BiologicalSL-28

    Doses administered: 6×10\^7 cells/injection, once daily, 5 days per week, 12 weeks. Mode of administration: intravenous push

  • BiologicalSL-28

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

06

What researchers measure

Primary outcomes

  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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 weeks

Secondary outcomes

  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.

    Time frame: 12 weeks

  2. Objective Response Rate (ORR) per iRECIST

    Objective Response Rate (ORR) per iRECIST

    Time frame: 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.

    Time frame: 12 weeks

07

Study locations

1 of 3 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jan 2027, 4 months after the start.

Of 74 phase 1/2 interventional studies under Esophageal Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 92. This study's planned 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2025
First posted
Jan 14, 2026
StartActual
Aug 14, 2026
Primary completionEst.
Jan 1, 2027
CompletionEst.
Mar 1, 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07341737
Lead sponsor
Second Life Therapeutics
Responsible party
Sponsor
First posted
Jan 14, 2026
Start date
Aug 14, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

George Tetz, MD, PhD
Contact
clinical@secondlifetx.com
16466173088

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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