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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma

Phase 1 Study to Evaluate the Safety and Efficacy of TILs Transduced With IL-7 (ADP-TILIL7) in Patients With Locally Advanced or Metastatic Melanoma

To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma (NCT06204991) is a Phase 1 interventional studying Melanoma Stage III and Melanoma Stage IV, sponsored by Inge Marie Svane. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The primary objective of this Phase 1 clinical trial is to evaluate the feasibility and tolerability of a novel generation of gene-modified tumor infiltrating lymphocytes (TILs) in a cohort of 10 patients aged 18-75 diagnosed with unresectable or metastatic melanoma. TILs will undergo transduction with the Interleukin-7 (IL-7) gene, for IL-7 production upon antigen engagement. Participants will undergo: * screening * tumor operation following autologous TIL production (incl. transduction) - takes approximately 4-6 weeks * admission for lymphodepleting chemotherapy (Cyclophosphamide and Fludarabine phosphate), TIL infusion and high-dose IL-2 infusions for a maximum of 6 doses * Following treatment, patients will undergo systematic and regularly planned assessments, encompassing clinical evaluation, biochemistry analyses, and PET/CT scans. This thorough follow-up regimen will be continued until any of the following events occur: progressive disease, withdrawal from study, or end of study, which spans a duration of 15 years for trials involving genetically modified organisms.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Melanoma Stage III, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - All the criteria listed in the following need to be met before patient inclusion. 1. diagnosed by tissue sample (biopsy-confirmed) inoperable or metastatic melanoma (stage IIIc or IV). 2. Progressive disease after standard treatment with PD-1 check-point inhibition or combination of aforementioned with CTLA-4 check-point inhibition. 3. Age: 18 - 75 years at time of signed willing to sign a consent form. 4. ECOG performance status of ≤ 1 (Appendix 2). 5. Is fit for tumor resection and has at least one lesion (\> 1 cm3) available for surgical resection for manufacture of TIL. 6. At least one measurable parameter in accordance with RECIST 1.1 -criteria (excluding lesion to be resected). 7. LVEF assessment with documented LVEF ≥50% by either TTE (transthoracic echocardiography) or MUGA (multigated acquisition scan). 8. Sufficient organ function, including: - Absolute neutrophil count (ANC) ≥ 1.500 /µl - Leucocyte count ≥ lower normal limit - platelet count at least 100.000 /µl and \<700.000 /µl - blood count (hemoglobin) at least 6.0 mmol/l - eGFR \> 70 ml/min\* - S-bilirubin ≤ 1.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 2.5 × ULN) - ASAT/ALAT ≤ 2.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 5.0 × ULN) - Alkaline phosphatase ≤ 5 times upper normal limit - Lactate dehydrogenase ≤ 5 times upper normal limit - Sufficient coagulation: APPT\<40 and INR\<1.5 - \* In selected cases it can be decided to include a patient with an eGFR \< 70 ml/min with the use of a reduced dose of chemotherapy. 9\. Signed statement of consent after receiving oral and written study information 10. Willingness to participate in the planned controls and capable of handling toxicities. 11\. Subject must receive T-cell therapy as the next therapy following tumor resection, unless bridging therapy is administered: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * All the criteria listed in the following need to be met before patient inclusion. 1. Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV). 2. Progressive disease after standard treatment with PD-1 check-point inhibition or combination of aforementioned with CTLA-4 check-point inhibition. 3. Age: 18 - 75 years at time of signed Informed consent. 4. ECOG performance status of ≤ 1 (Appendix 2). 5. Is fit for tumor resection and has at least one lesion (\> 1 cm3) available for surgical resection for manufacture of TIL. 6. At least one measurable parameter in accordance with RECIST 1.1 -criteria (excluding lesion to be resected). 7. LVEF assessment with documented LVEF ≥50% by either TTE (transthoracic echocardiography) or MUGA (multigated acquisition scan). 8. Sufficient organ function, including: * Absolute neutrophil count (ANC) ≥ 1.500 /µl * Leucocyte count ≥ lower normal limit * Platelets ≥ 100.000 /µl and \<700.000 /µl * Hemoglobin ≥ 6.0 mmol/l * eGFR \> 70 ml/min\* * S-bilirubin ≤ 1.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 2.5 × ULN) * ASAT/ALAT ≤ 2.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 5.0 × ULN) * Alkaline phosphatase ≤ 5 times upper normal limit * Lactate dehydrogenase ≤ 5 times upper normal limit * Sufficient coagulation: APPT\<40 and INR\<1.5 * \* In selected cases it can be decided to include a patient with an eGFR \< 70 ml/min with the use of a reduced dose of chemotherapy. 9\. Signed statement of consent after receiving oral and written study information 10. Willingness to participate in the planned controls and capable of handling toxicities. 11\. Subject must receive T-cell therapy as the next therapy following tumor resection, unless bridging therapy is administered: * Bridging therapy is discouraged. However, if in the opinion of the Investigator, the subject requires immediate therapy after tumor resection, the subject may receive bridging therapy for the period during which the subject is awaiting the manufacture of TIL-infusion product. Bridging therapy may be a continuation of the therapy the subject was receiving prior to tumor resection or may be a new therapy. * Following this bridging therapy, the subject must adhere to the mandatory washout periods (exclusion criterion 1) and must continue to have measurable disease prior to receiving T-cell therapy. 12\. Age and Reproductive Status: * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test AND must agree to use an effective method of contraception starting at the first dose of chemotherapy for at least 12 months. WOCBP must also agree to refrain from egg donation, storage, or banking during these same time periods. The following are considered safe methods of contraception: * Hormonal anticonception (birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch) * Intrauterine device * Surgical sterilization * Surgical sterilization of male partner with verification of no sperm after the procedure * Menopause (for more than 12 months) o Male subjects must be surgically sterile or agree to use a double-barrier contraception method or abstain from sexual activity with an WOCBP starting at the first dose of chemotherapy and for 6 months thereafter. Male subjects must also agree to refrain from sperm donation, storage, or banking. Exclusion Criteria: * Patients will be excluded if they meet one of the criteria's listed below 1. Subject has received or plans to receive the following therapy/treatment prior to tumor resection (TR) or lymphodepleting chemotherapy (LDC): * Cytotoxic chemotherapy: Washout period 3 weeks before TR and LDC * Small molecules/TKI: Washout period 1 week before TR and LDC * Immune therapy (monoclonal AB therapy, CPI and biologics): 2 weeks before TR and LDC * Prior T-cell therapy, including gene therapy using an integrating vector * Corticosteroids at dose equivalent \> 10 mg prednisone or any other immunosuppressive therapy. 2 weeks before TR and LDC. Note: Use of topical steroids is not an exclusion * Investigational treatment: 4 weeks or 5 half-lives, whichever is shorter before TR and LDC * Radiation to the pelvis and/or multiple bones containing ≥ 25% of bone marrow: 4 weeks before TR and LDC * Whole brain radiotherapy or brain stereotactic radiosurgery: 4 weeks before TR and LDC * Radiotherapy to the target lesions: 3 months prior to TIL-infusion. A lesion with unequivocal progression post-radiotherapy may be considered a target lesion. 2. A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable. 3. Patients with metastatic ocular/mucosal or other non-cutaneous melanoma. Unknown primary melanoma is eligible. 4. Toxicity from previous anti-cancer therapy must have resolved to ≤ Grade 1 or baseline prior to enrollment (except for non-clinically significant toxicities e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities who are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled. 5. Patients who have more than 2 CNS metastases or who have any CNS lesion that is symptomatic, greater than 1 cm in diameter or show significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clincal or radiologic CNS progression for at least 2 months. 6. The following patients will be excluded because of inability to receive high dose interleukin-2: * History of coronary revascularization * Patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, 2o or 3o heart block * Documented FEV-1 less than or equal to 60% predicted value for patients with: A prolonged history of cigarette smoking (greater than 20 pack years), large tumor burden in the lungs or Symptoms of respiratory distress. 7. Known hypersensitivity to one of the active drugs or one or more of the excipients. 8. Severe medical conditions, such as severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others. 9. Acute/chronic infection with HIV, hepatitis, syphilis among others. 10. Severe allergies or previous anaphylactic reactions. 11. Active autoimmune or immune-mediated disease that has not yet resolved. Subjects with the following will be eligible: * Immune-mediated AEs secondary to immunotherapy which has resolved to ≤ Grade 1 off steroids; * Hypothyroidism, Type I diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy; * Disorders such as asthma, vitiligo, psoriasis, or atopic dermatitis that are well controlled without requiring systemic immunosuppression; * Other stable immune conditions that do not require prednisone higher than 10 mg/day or their equivalent dose for other corticosteroid agents may be acceptable with the agreement of the Sponsor. 12. Pregnant women and women breastfeeding. 13. Subject who, in the opinion of the Investigator, will be unlikely to fully comply with protocol requirements.

Treatments Being Tested

BIOLOGICAL

ADP-TILIL7

Autologous tumor infiltrating lymphocytes genemodified (by a lentiviral vector) to produce IL-7 upon antigen engagement

DRUG

Cyclophosphamide

Lymphodepleting Chemotherapy

DRUG

Fludarabine Phosphate

Lymphodepleting Chemotherapy

DRUG

Proleukin

IL-2

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Department of Oncology
Herlev, Denmark
Department of Oncology
Herlev, Denmark

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06204991), the sponsor (Inge Marie Svane), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06204991 clinical trial studying?

The primary objective of this Phase 1 clinical trial is to evaluate the feasibility and tolerability of a novel generation of gene-modified tumor infiltrating lymphocytes (TILs) in a cohort of 10 patients aged 18-75 diagnosed with unresectable or metastatic melanoma. TILs will undergo transduction with the Interleukin-7 (IL-7) gene, for IL-7 production upon antigen engagement. Participants will undergo: * screening * tumor operation following autologous TIL production (incl. transduction) - takes approximately 4-6 weeks * admission for lymphodepleting chemotherapy (Cyclophosphamide and Fluda… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06204991?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06204991?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06204991. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06204991. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.