A Phase 1 interventional study of ADP-TILIL7 and Cyclophosphamide in Melanoma Stage III, Melanoma Stage IV and Melanoma, sponsored by Inge Marie Svane. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Inge Marie Svane · Phase 1, Interventional, and Treatment
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:
Synopsis:
Over the last decade treatment for malignant melanoma (MM) has seen remarkable progress particularly with checkpoint inhibitors (anti-PD-1 and anti-CTLA-4). The combination of these inhibitors has elevated the 5-year overall survival (OS) from 5 % to 50 %. However, many patients still lack a durable response.
Results from a Phase III trial, conducted in part at CCIT-DK, have illuminated the promising potential of adoptive cell therapy utilizing tumor infiltrating lymphocytes (TILs) in the treatment of malignant melnaoma. In this trial, 168 patients were randomly assigned to receive either standard anti-CTLA-4 treatment or TILs. The outcomes revealed a notably superior overall response rate (ORR) and a higher number of complete responses (CR) among those treated with TILs.
In this phase I study the investigators intend to treat 10 subjects with locally advanced or metastatic MM. Included subjects undergo surgical removal of tumor tissue for TIL manufacturing. During TIL manufacture, the investigators will genetically modify the TILs, and enable them to produce Interleukin-7 (IL-7). This modification is anticipated to confer additional functionality to the TILs enhancing their proliferation and persistence. The lentiviral vector used to integrate the IL-7 gene to the TILs is manufactured and provided by the British/American biotechnological company, Adaptimmune. The genetically modified TILs are therefore called ADP-TILIL7.
Lymphodepleting (LD) chemotherapy is administered 7 days prior to ADP-TILIL7 infusion. ADP-TILIL7 infusion is followed by high dose (HD) Interleukin (IL-2) for a maximum of 6 doses or until tolerance.
Purpose:
The primary objective of this study is to evaluate the tolerability and safety of treatment with ADP-TILIL7. The secondary objective is to assess the clinical effect of the treatment by use of the objective response rate (using RECIST 1.1). Overall survival (OS), progression-free survival (PFS), duration of response (DoR) and disease control rate (DCR) will be determined. In addition to this replication competent lentivirus (RCL) will be monitored.
Exploratory objectives are to characterize the tumor and tumor microenvironment pre- and post infusion, ex by genomic profiling of tumor tissue to investigate the mutational landscape. Furthermore, the expression of tumor-associated immunerelated markers, including markers of phenotype and frequency of tumor infiltrating blood-derived cells. The investigators want to characterize subjects' peripheral blood which includes, but is not limited to, the phenotype and funcitionality of transduced TILs and non-transduced TILs, as well as the pharmacodynamic changes in whole blood and serum pre- and post infusion, which might include gene expression, TCR/B-cell receptor repertoire, cytokines and soluble markers. All this the investigators want to explore to understand factors that can influence response or resistance to ADP-TILIL7 therapy.
Study design:
This is a phase I, First-in-human, study. Ten (10) subjects with locally advanced or metastatic MM will be included and treated at the Department of Oncology, Herlev Hospital. Subjects can be referred from other oncology centers.
Subjects will undergo a comprehensive screening process to confirm subjects' eligibility before enrollment. Included subjects will undergo surgical tumor removal for the subsequent manufacturing of TIL's. TheTIL manifacturing process is expected to take approximately 4-6 weeks. During TIL manufacture, a subset of the TILs will be transduced with genetic material encoding the production of IL-7.
Lymphodepleting chemotherapy, Cyclophosphamide and Fludarabine phosphate, will be administered for 7 days prior to ADP-TILIL7 infusion. ADP-TILIL7 infusion is followed by high-dose IL-2 for a maximum of 6 doses or until tolerance. After the end of treatment, the subjects will be followed with clinical- and imaging controls for up to 15 years.
The inclusion period is set to commence in early 2024, with the goal of enrolling all ten patients within a span of three years. The study's completion is defined as the moment when the last subject reaches and complete the 12 months follow-up visit. The study ends once all treated subjects complete 15 years of follow-up, passes away or withdraw from the study.
The study will be monitored by the Good Clinical Practice (GCP)-unit of the Capital Region of Denmark. The Danish Medicines Agency, The GCP-unit, and Adaptimmune are allowed to audit this trial.
Population:
This study targets subjects aged 18 to 75, histologically confirmed with malignant melanoma who have experienced progression following at least one line of immune checkpoint inhibitor in the advanced or metastatic setting. Eligibility is contigent on meeting specific inclusion criteria, including acceptable performance status, kidney- and liver function, and the absence of major co-morbidities. Crucially, treatment will proceed only for the subjects with successful manufacturing of TILs. Previous clinical trials have demonstrated a success rate of TIL manufacturing from malignant melanoma exceeding 90%.
Toxicity:
The amount of toxicity caused by ADP-TILIL7 is not known. The systemic treatment with IL-7 infusion has been used in treatment of several malignancies and HIV and as an adjunct to allogeneic stem cell transplantation. In these studies, IL-7 has exhibited a generally well-tolerated safety profile. At CCIT-DK investigators boast substantial experience in treating subjects with TILs that have not been genetically modified. TIL therapy has generally been well-tolerated, with most adverse events expected to be associated with chemotherapy and high-dose IL-2 treatment.
Dosing in the first three subjects will be staggered. Each subject will have safely completed a minimum observation period of 14 days from the ADP-TILIL7 infusion before lymphodepletion of the next subject commences.
Toxicity assessment, including evaluation of treatment limiting toxicity (TLTs), will be performed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The TLT observation period will be during the first 21 days following the ADP-TILIL7 infusion.
Evaluation of clinical response:
Subjects enrolled in the study will undergo comprehensive clinical evaluations during treatment and hospitalization as well as 6, 12 and 24 weeks post-treatment with ADP-TILIL7. Thereafter clinical evaluation will take place every 3 months the first two years (year 1-2), every 6 months year 3-5, followed by evaluations every 12 months year 6-15. Diagnostic imaging, preferably PET/CT scans, will be conducted before the treatment initiation, and in conjunction with the clinical evaluations, commencing 6 weeks post-TIL treatment.
Immunological response evaluation:
Blood samples for research purposes will be systematically collected at Baseline, pre- and post-TIL infusion (day 0), during IL-2 (up to a maximum 3 days), before discharge and at week 6, week 12 and the final collection 12 months post-ADP-TILIL7/progressive disease/withdrawal whichever occurs first. Blood samples for research purposes will be selectively collected, contigent upon feasibility as assessed by the investigator. Biopsies from metastatic tumor tissue will be systematically obtined at key time points: before treatment initiation, 6 weeks post-treatment and, if applicable and deemed safe, in case of disease progression.
3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 2,649 interventional studies indexed under Melanoma.
Browse Melanoma studies →Inge Marie Svane is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
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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.
All the criteria listed in the following need to be met before patient inclusion.
Sufficient organ function, including:
* 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:
Following this bridging therapy, the subject must adhere to the mandatory (exclusion criterion 1) and must continue to have prior to receiving T-cell therapy.
12. Age and Reproductive Status:
Exclusion Criteria:
Patients will be excluded if they meet one of the criteria's listed below
Subject has received or plans to receive the following therapy/treatment prior to tumor resection (TR) or lymphodepleting chemotherapy (LDC):
Toxicity from previous anti-cancer therapy must have resolved to ≤ Grade 1 or baseline prior to enrollment (except for non- toxicities e.g., alopecia, vitiligo).
Subjects with Grade 2 toxicities who are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
The following patients will be excluded because of inability to receive high dose interleukin-2:
Active or immune-mediated disease that has not yet resolved. Subjects with the following will be eligible:
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
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).
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.
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.
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.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
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.
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.
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.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tumor-infiltrating lymphocytes grown ex-vivo from resected tumor tissue and reapplied to the patient via an intravenous infusion. Drug: Cyclophosphamide: 2 doses (69 mg/kg) prior to infusion Drug: Fludarabinephosphat 5 doses (25 mg/m2, max. 50 mg) prior to infusion Drug: Proleukin 600.000 IU/kg/dose IL-2 a maximum of 6 doses
Biological: ADP-TILIL7 · Drug: Cyclophosphamide · Drug: Fludarabine Phosphate · Drug: Proleukin
Autologous tumor infiltrating lymphocytes genemodified (by a lentiviral vector) to produce IL-7 upon antigen engagement
Lymphodepleting Chemotherapy
Lymphodepleting Chemotherapy
IL-2
Tolerability of the treatment
Fraction of subjects experiencing grade \>/= 3 AE
Time frame: Through study completion, an average of 1 year
Feasibility of the treatment
Measured by the number of subjects who undergo surgery and succesfully undergo ADP-TILIL7-infusion
Time frame: Through study completion, an average of 1 year
Objective response rate
Defined as the proportion of subjects who have a partial or complete response to therapy. Response evaluation criteria in solid tumors, RECIST 1.1. criterias assesed by CT scan
Time frame: Until progression up to 15 years
Overall survival
Time from initiation of treatment to death
Time frame: 15 years
Progression free survival
Time from initiation of treatment until first evidence of disease progression or death
Time frame: Until progression or death up to 15 years
Duration of response
Time from initiation of treatment to disease progression or death in subjects who achieve complete or partial response
Time frame: 15 years
Disease control rate
The percentage of subjects whose therapeutic intervention has led to a complete response, partial response or stable disease.
Time frame: 15 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Inge Marie Svane