MelanomaNCT07028008
Evaluate the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocyte in Patients With Refractory Melanoma Who Failed to Immune Checkpoint Inhibitors
A study testing tumor-infiltrating lymphocyte (TIL) in people with Melanoma, run by Samsung Medical Center.
Trial summary
For cancer patients who have failed conventional chemotherapy or are inoperable, targeted therapies-which block specific proteins involved in tumor growth-and immunotherapies-which activate T cells around the tumor to induce tumor cell death-have emerged as powerful treatment options. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Melanoma
- What is being tested?
- tumor-infiltrating lymphocyte (TIL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2025to 28 May 2029
- Phase
- Interventional
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥19 and ≤80 years at the time of informed consent.
- Histologically or cytologically confirmed melanoma, classified as refractory/unresponsive Stage IIIc or IV after failure of prior immune checkpoint inhibitor therapy.
- At least one measurable and evaluable lesion as defined by RECIST version 1.1.
- ECOG performance status of 0 or 1.
- Estimated life expectancy ≥12 weeks.
- Ability to undergo tumor tissue biopsy for the purpose of producing a sufficient quantity of autologous tumor-infiltrating lymphocytes (CT-SP).
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- Willingness to undergo tissue collection procedures after enrollment in the study.
- For surgical specimens: at least one lesion with a minimum diameter of 1 cm. For biopsy samples: a minimum of 20-25 tissue fragments must be obtainable.
- Adequate organ function as defined by the following laboratory values (up to two retests permitted; transfusions or medical correction allowed):
- Hemoglobin ≥ 9.0 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,500/μL
- Absolute Lymphocyte Count (ALC) ≥ 500/μL
- Platelet count ≥ 100,000/μL
- Serum creatinine clearance (estimated by Cockcroft-Gault) ≥ 50 mL/min
- Total bilirubin ≤ 2.0 mg/dL
- AST and/or ALT ≤ 3 × ULN (≤ 5 × ULN if liver metastasis is present)
- Subjects of childbearing potential must agree to use acceptable contraceptive methods during the study, including but not limited to:
- Complete abstinence, Sterilization (patient or partner), Intrauterine device, Hormonal contraception, Barrier methods (e.g., condom + spermicide, diaphragm)
- Written informed consent voluntarily provided before any study-specific procedures are conducted.
Who cannot join
- History of solid organ transplantation.
- Diagnosis of another malignancy within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or non-invasive cervical cancer.
- History of active or latent tuberculosis infection within 1 year prior to screening (except for those declared cured after treatment).
- Pregnant or breastfeeding women.
- Positive test for anti-HIV antibodies.
- Active HBV or HCV infection considered clinically inappropriate for study participation by the investigator.
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- Uncontrolled central nervous system (CNS) metastases (note: patients with treated and stable brain metastases for ≥30 days prior to screening are eligible).
- Any surgery, radiotherapy, or systemic anticancer therapy within 3 weeks prior to CT-SP administration.
- Participation in another interventional clinical trial and receipt of any investigational drug within 3 weeks prior to CT-SP administration.
- Known hypersensitivity or contraindication to: Cyclophosphamide, Fludarabine, Interleukin-2 (IL-2), CT-SP excipients: 5% human serum albumin, sterile saline, 5% DMSO
- Unresolved toxicity from prior therapy not recovered to Grade ≤1 (per NCI CTCAE v5.0), except for clinically non-significant events such as alopecia.
- Receipt of systemic immunosuppressive therapy (including corticosteroids) within 10 days prior to tumor tissue collection for CT-SP manufacturing (exceptions: local/inhaled steroids; systemic corticosteroids ≤ prednisolone 20 mg/day equivalent may be permitted at investigator discretion).
- Clinically significant cardiovascular disease, including but not limited to:
- Uncontrolled hypertension (systolic BP > 180 mmHg and/or diastolic BP > 100 mmHg), Unstable angina, Pulmonary embolism, Cerebrovascular accident, Valvular heart disease, Congestive heart failure (NYHA Class III or IV), Myocardial infarction or significant arrhythmia within 24 weeks prior to screening
- Known contraindications to dopamine or other pressor agents.
- Other serious comorbid medical conditions that may interfere with study participation, as determined by the investigator.
- Active or severe infection requiring hospitalization or intravenous antibiotics, deemed unsuitable for participation by the investigator.
- Significant psychiatric illness that, in the investigator's opinion, may affect subject compliance or study conduct.
- Subjects with autoimmune or inflammatory disorders, where the investigator deems abnormal autoantibody test results to be clinically relevant.
- Any other condition not listed above that the investigator considers to make the subject ineligible for participation.
- Subjects determined to be unsuitable for participation based on the anticipated manufacturing timeline and logistics of CT-SP.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocyte (CT-SP) in Patients With Refractory Melanoma Who Failed to Immune Checkpoint Inhibitors
For cancer patients who have failed conventional chemotherapy or are inoperable, targeted therapies-which block specific proteins involved in tumor growth-and immunotherapies-which activate T cells around the tumor to induce tumor cell death-have emerged as powerful treatment options. These therapies often result in longer survival with fewer side effects compared to traditional chemotherapy. However, a significant proportion of patients do not respond to either targeted therapies or immunotherapies, and treatment options for these individuals remain extremely limited.
One of the most notable immunotherapies, immune checkpoint inhibitors, works by blocking immune checkpoint proteins (such as PD-1 and CTLA-4) to activate T cells within the tumor microenvironment, thereby enabling them to attack cancer cells. This approach has demonstrated remarkable efficacy in various solid tumors, including melanoma. Nonetheless, for many patients with immunologically "cold" tumors characterized by low infiltration of T cells, these therapies show low objective response rates, indicating the need for more proactive treatment strategies.
In this study, we aim to administer the tumor-infiltrating lymphocyte (TIL) therapy CT-SP to patients with refractory melanoma, primarily to assess safety, and further to evaluate its anti-tumor efficacy by examining improvements in objective response rate (ORR) and progression-free survival (PFS). If this advanced regenerative clinical study demonstrates that CT-SP is both safe and effective, it could offer a powerful new treatment option for patients with refractory melanoma in Korea.
- Conditions
- Melanoma
- Being tested
- tumor-infiltrating lymphocyte (TIL)
- Keywords
- melanoma, TIL
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor-infiltrating lymphocyte (TIL)Biological
tumor-infiltrating lymphocyte (TIL): CT-SP 1~100 x10 9 cells
| Study group | Role | What they receive |
|---|---|---|
| tumor-infiltrating lymphocyte (TIL) therapy | Experimental | 1~100 x 10 9 cells, 1time, IV Receives: Biological: tumor-infiltrating lymphocyte (TIL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
Incidence of tumor infiltration lymphocyte (CT-SP) treatment Adverse Events as assessed by CTCAE v5.0
Measured: up to 6 months after TIL administration
Secondary outcomes (5)
Overall Response Rate
modified Recist v1.1
Measured: Up to 60months
Duration of Response
modified Recist v1.1
Measured: Up to 60months
Disease Control Rate
modified Recist v1.1
Measured: Up to 60months
Progression Free Survival
modified Recist v1.1
Measured: Up to 60months
Overall Survival
modified Recist v1.1
Measured: Up to 60months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start15 Oct 2025 (estimated)
- Primary completion28 May 2027 (estimated)
- Study completion28 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028008
- Sponsor's protocol ID
- 2025-06-022
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocyte (CT-SP) in Patients With Refractory Melanoma Who Failed to Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT07028008
- Acronym / sponsor ID
- 2025-06-022
- Conditions
- Melanoma
- Keywords
- melanoma, TIL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 28 May 2027 (estimated)
- Study completion
- 28 May 2029 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For cancer patients who have failed conventional chemotherapy or are inoperable, targeted therapies-which block specific proteins involved in tumor growth-and immunotherapies-which activate T cells around the tumor to induce tumor cell death-have emerged as powerful treatment options. These therapies often result in longer survival with fewer side effects compared to traditional chemotherapy. However, a significant proportion of patients do not respond to either targeted therapies or immunotherapies, and treatment options for these individuals remain extremely limited.
One of the most notable immunotherapies, immune checkpoint inhibitors, works by blocking immune checkpoint proteins (such as PD-1 and CTLA-4) to activate T cells within the tumor microenvironment, thereby enabling them to attack cancer cells. This approach has demonstrated remarkable efficacy in various solid tumors, including melanoma. Nonetheless, for many patients with immunologically "cold" tumors characterized by low infiltration of T cells, these therapies show low objective response rates, indicating the need for more proactive treatment strategies.
In this study, we aim to administer the tumor-infiltrating lymphocyte (TIL) therapy CT-SP to patients with refractory melanoma, primarily to assess safety, and further to evaluate its anti-tumor efficacy by examining improvements in objective response rate (ORR) and progression-free survival (PFS). If this advanced regenerative clinical study demonstrates that CT-SP is both safe and effective, it could offer a powerful new treatment option for patients with refractory melanoma in Korea.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tumor-infiltrating lymphocyte (TIL) therapy | Experimental | Biological: tumor-infiltrating lymphocyte (TIL)1~100 x 10 9 cells, 1time, IV |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥19 and ≤80 years at the time of informed consent.
- Histologically or cytologically confirmed melanoma, classified as refractory/unresponsive Stage IIIc or IV after failure of prior immune checkpoint inhibitor therapy.
- At least one measurable and evaluable lesion as defined by RECIST version 1.1.
- ECOG performance status of 0 or 1.
- Estimated life expectancy ≥12 weeks.
Key exclusion criteria (21 listed)
- History of solid organ transplantation.
- Diagnosis of another malignancy within the past 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or non-invasive cervical cancer.
- History of active or latent tuberculosis infection within 1 year prior to screening (except for those declared cured after treatment).
- Pregnant or breastfeeding women.
- Positive test for anti-HIV antibodies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tumor-infiltrating lymphocyte (TIL)tumor-infiltrating lymphocyte (TIL): CT-SP 1~100 x10 9 cells | Biological | tumor-infiltrating lymphocyte (TIL) therapy |
Primary outcome
Safety evaluation
Time frame: up to 6 months after TIL administration
Incidence of tumor infiltration lymphocyte (CT-SP) treatment Adverse Events as assessed by CTCAE v5.0
5 secondary outcomes
Overall Response Rate
Time frame: Up to 60months
Duration of Response
Time frame: Up to 60months
Disease Control Rate
Time frame: Up to 60months
Progression Free Survival
Time frame: Up to 60months
Overall Survival
Time frame: Up to 60months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing tumor-infiltrating lymphocyte (TIL) in people with Melanoma, run by Samsung Medical Center.
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 19 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: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Jeeyun Lee Principal Investigator, MD (82-2-3410-3459, jyun.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation (time frame: up to 6 months after TIL administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.