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Metastatic MelanomaPhase 1TUNINTIL-2NCT06961786

TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma

A Phase 1 study testing TILT-123, TIL and Cyclophosphamide in people with Metastatic Melanoma, run by TILT Biotherapeutics Ltd. at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, phase 1 trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with lymphocyte-depleting chemotherapy and TILs in metastatic melanoma patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Melanoma
What is being tested?
TILT-123, TIL and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteDenmark
Study dates
25 Jun 2025to Apr 2027
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
  • Patients with pathologically confirmed previously treated refractory or recurrent stage 3-4 melanoma, which cannot be treated with curative intent with available therapies.
  • Patients who have had at least 1 prior line of medical treatment (eg, checkpoint inhibitors, kinase inhibitors, IL-2). Multiple prior therapies (eg, surgery, checkpoint inhibitors, kinase inhibitors, IL-2, interferon, chemotherapy, radiation) are allowed.
  • Patients must have a demonstrated WHO/ECOG performance score of 0-1 at screening.
  • A tumor of >9 mm in diameter (typically a minimum of 1 cm3 in volume), without signs of necrosis, must be available for biopsy/operation to enable growing of TILs.
  • At least 1 additional tumor (>14 mm in diameter) must be available for injections and biopsies for correlative analyses. The disease burden must be evaluable according to RECIST 1.1.
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  • Patients must have adequate hepatic, cardiac, and renal function as follows:
  • Platelets ≥ 100,000/µl and < 700,000/µl
  • Hemoglobin ≥100 g/L
  • AST and ALT ≤2.5×ULN
  • GFR >60 mL/min (CKD-EPI)
  • Leukocytes (WBC) >3.0G/L
  • Absolute neutrophil count greater than 1500/mm3 without the support of filgrastim
  • Bilirubin <1.5×ULN
  • Patients of 60 years or older, or have a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, heart block, will undergo cardiac evaluation: LVEF assessment with documented LVEF ≥ 50% by either TTE (trans thoracal echocardiography) or MUGA (multigated acquisition scan). Further cardiac evaluations in patients with cardiac risk factors (e.g. diabetes, hypertension, obesity) will be evaluated by the investigator as deemed necessary.
  • Must be willing to use adequate forms of contraception from screening, during the study, and for a minimum of 90 days after the end of treatment, in accordance with the following:
  • Woman of childbearing potential: Barrier contraceptive method (ie, condom) must be used in addition to 1 of the following methods: Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections).
  • Women not of childbearing potential: Barrier contraceptive method (ie, condom) must be used.
  • Men: Barrier contraceptive method (ie, condom) must be used.
  • Patients must be capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Patients must be capable of understanding and complying with the parameters outlined in the protocol.
  • Patients must have a life expectancy longer than 3 months.
  • Patients must be eligible for adoptive T-cell therapy with Lymphocyte-depleting chemotherapy and TILs.

Who cannot join

  • History of another active invasive cancer as judged by the investigator within the past 3 years except basal cell carcinoma.
  • Uncontrolled cardiac or vascular diseases.
  • History of heart attack or cerebral stroke within the previous 12 months before screening or is not recovered from a previous heart attack or cerebral stroke.
  • History of hepatic dysfunction, hepatitis, or human immunodeficiency virus.
  • Patients should be seronegative for HIV antibody.
  • Patients should be seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
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  • History of coagulation disorder.
  • Untreated brain metastases. Treated brain metastases that have not progressed in the 3 months prior to screening are allowed.
  • Concurrent opportunistic and/or active systemic infections.
  • Use of immunosuppressive medications (corticosteroids or drugs used in treatment of autoimmune disease), except for the following, which can be allowed at screening and during the study:
  • Replacement corticosteroids (eg, if the patient has adrenal insufficiency after prior immunotherapy)
  • Pulmonary and topical treatments
  • Prednisone/prednisolone at doses up to 20 mg/day
  • Treated with any anticancer therapy (eg, immunotherapy, signal-transduction inhibitors [eg. BRAF and MEK inhibitors], cytotoxic chemotherapy, radiotherapy, or investigational agents [ie, any drug or therapy that is currently not approved for use in humans]) within 30 days prior to enrollment.
  • Previously treated with any oncolytic adenovirus that was administered IT.
  • Previously treated with adoptive cell therapy.
  • Administered an IMP or device in another clinical study within 30 days prior to baseline.
  • Lactate dehydrogenase value >5×ULN.
  • Allergy to any ingredients present in the IMPs (as listed in the respective IBs).
  • Women of childbearing potential who are pregnant, breastfeeding, or intending to become pregnant.
  • Any other medical condition or laboratory abnormality that, in the judgment of the principal investigator, could increase the risk associated with study participation, interfere with interpretation of study results, or otherwise render study participation inappropriate.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • National Center for Cancer Immune Therapy Herlev Hospital, Copenhagen University

    Copenhagen

Other trials in Denmark

About this study

Official title: A Phase 1, Open-label, Single-arm Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of TNFa and IL-2 Coding Oncolytic Adenovirus TILT-123 in Combination With Lymphocyte-depleting Chemotherapy and Tumor-infiltrating Lymphocytes in Melanoma Patients.

This is an open-label, phase 1 trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with lymphocyte-depleting chemotherapy and TILs in metastatic melanoma patients.

Read the detailed description

TILT-123 is a tumor-selective replicating oncolytic adenovirus expressing TNFa and IL-2 that is being investigated in several Phase 1 clinical studies in patients with various types of cancer. This is the second study of TILT-123 in patients with metastatic melanoma. Building upon the previous study, TILT-T215, which evaluated the safety and preliminary efficacy of TILT-123 in combination with TILs, Study TILT-T216 will investigate the addition of lymphocyte-depleting chemotherapy to the combination of TILT-123 and TILs. The purpose of lymphodepleting chemotherapy, cyclophosphamide and fludarabine phosphate is to reduce irrelevant T cells and eliminate the regulatory T cells, which are known to be able to inhibit T-cell mediated tumor cell killing.

Being tested
TILT-123, TIL, Cyclophosphamide, Fludarabine
Keywords
oncolytic virus, TILT, immunotherapy
Medical subject headings
Melanoma

What participants receive

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

  • TILT-123Biological

    Also called Ad5/3-E2F-d24-hTNFa-IRES-hIL2

    TNFalpha and IL-2 coding oncolytic adenovirus TILT-123

  • TILBiological

    Also called Tumor-infiltrating lymphocytes

    Adoptive T cell therapy with TILs

  • CyclophosphamideDrug

    Also called Cytoxan, cyclophosphane

    Lymphocyte-depleting chemotherapy

  • FludarabineDrug

    Also called Fludara

    Lymphocyte-depleting chemotherapy

Study groups in NCT06961786
Study groupRoleWhat they receive
TILT-123, TILs and chemotherapyExperimentalTILT-123 in combination with lymphocyte-depleting chemotherapy and TILs
Receives: Biological: TILT-123; Biological: TIL; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. Number of Participants with any (serious and non-serious) Adverse Events

    Adverse events

    Measured: 78 days

  2. Number of Participants with abnormal laboratory values

    Laboratory values

    Measured: 78 days

  3. Number of Participants with vital sign abnormalities

    Vital signs

    Measured: 78 days

  4. Safety assessed by 12- lead electrocardiograms (ECGs) Adverse Events

    Clinically significant abnormalities detected in the evaluation (including for example rate, rhythm, axis calculations and interpretation of P, Q, R, S, T U waves, segments and basic ECG calculations) will be recorded

    Measured: 78 days

Timeline

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

  1. First posted8 May 2025
  2. Study start25 Jun 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionApr 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06961786
Sponsor's protocol ID
TILT-T216
Other IDs
2024-514092-18-00
Acronym
TUNINTIL-2
Status last verified
Mar 2026
First submitted
23 Apr 2025
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TILT-123, TIL and Cyclophosphamide in people with Metastatic Melanoma, run by TILT Biotherapeutics Ltd. at 1 site in Denmark.

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 23 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with any (serious and non-serious) Adverse Events (time frame: 78 days). The study lists 4 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 NCT06961786.

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 5 Mar 2026.

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