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Supercharged T-Cells take on melanoma in early trial

NCT ID NCT01955460

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests whether giving patients with advanced melanoma immune cells that have been genetically modified to resist tumor-suppressing signals can help fight the cancer. The modified T-cells are given along with high-dose Interleukin-2, a drug that boosts immune activity. The study involves 34 patients and focuses on safety and whether the modified cells can be successfully produced and administered.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
genetically modified T-cells (TGF-beta resistant) plus aldesleukin (high-dose Interleukin-2)
What this could lead to
If successful, this approach could point toward a more effective treatment for advanced melanoma by making immune cells resistant to tumor-suppressing signals.
What could go wrong
This is a very early phase 1 trial with only 34 participants, so it is primarily testing safety and feasibility. The modified T-cells may not work as expected, and high-dose IL-2 can cause severe side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2014

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or regional nodal disease (Turnstile I) * Patients must have a lesion amenable to resection or the collection of up to 5 needle core samples for the generation of TIL. (Turnstile I) * Patients must receive a magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) of the brain within 6 months of signing informed consent; if new lesions are present, patient must have definitive treatment; principal investigator (PI) or his designee should make final determination regarding enrollment (Turnstile I) * Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-2 within 30 days of signing informed consent (Turnstile I) * Patients previously treated with immunotherapy, targeted therapy, or no therapy (treatment naive) will be eligible (Turnstile I) * Patients receiving cytotoxic agents will be evaluated by the PI or his designee for eligibility suitability (Turnstile I) * Patients with a negative pregnancy test (urine or serum) must be documented within 14 days of screening for women of childbearing potential (WOCBP); a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e. who has not had menses at any time in the preceding 12 consecutive months) (Turnstile I) * Patients must have adequate TIL available (Turnstile II); pre-rapid expansion procedure (Pre-REP) TIL generated in the similar clinical trial 2004-0069 may also be utilized for Turnstile II * Patients must have at least one biopsiable measurable metastatic melanoma, lesion \> or = to 1 cm (Turnstile II) * Patients may have brain lesions =\< 1 cm each; the PI or designee will approve the treatment (Turnstile II) * Patients of both genders must practice birth control for four months after receiving the preparative regimen (lymphodepletion) and continue to practice birth control throughout the study; patients must have a documented negative pregnancy test (urine or serum) for women who have menstruation in the past 12 months and without sterilization surgery (Turnstile II) * Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, intrauterine device (IUD), or sponge plus spermicide; abstinence is an acceptable form of birth control (Turnstile II) * Patients with negative pregnancy test (urine or serum) must be documented within 14 days of screening for WOCBP; a WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e. who has not menses at any time in the preceding 12 consecutive months) (Turnstile II) * Clinical performance status of ECOG 0-2 within 30 days of signing informed consent (Turnstile II) * Absolute neutrophil count greater than or equal to 1000/mm\^3 (Turnstile II) * Platelet count greater than or equal to 100,000/mm\^3 (Turnstile II) * Hemoglobin greater than or equal to 8.0 g/dl (Turnstile II) * Serum alanine aminotransferase (ALT) less than three times the upper limit of normal (Turnstile II) * Serum creatinine less than or equal to 1.6 mg/dl (Turnstile II) * Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl (Turnstile II) * A stress cardiac test (stress thallium, stress multi gated acquisition scan \[MUGA\], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II) * Pulmonary function tests (forced expiratory volume in one second \[FEV1\] \> 65% or forced vital capacity \[FVC\] \> 65% of predicted) within 6 months of lymphodepletion (Turnstile II) * MRI/CT/PET of the brain within 30 days of lymphodepletion (Turnstile II) Exclusion Criteria: * Active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile I) * Primary immunodeficiency and need for chronic steroid therapy, however prednisone is allowed at \< 10 mg/day (Turnstile I) * Patients who are pregnant or nursing (Turnstile I) * Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent (Turnstile I) * Has had prior systemic cancer therapy within the past four weeks or v-raf murine sarcoma viral oncogene homolog B (B-RAF) or mitogen-activated protein kinase (MEK) inhibitors within 7 days at the time of the start of the lymphodepletion regimen (Turnstile II) * Women who are pregnant will be excluded because of the potentially dangerous effects of the preparative chemotherapy on the fetus (Turnstile II) * Any active systemic infections requiring intravenous antibiotics, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, such as abnormal stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease; PI or his designee shall make the final determination regarding appropriateness of enrollment (Turnstile II) * Any form of primary or secondary immunodeficiency; must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (\> 500/mm\^3), white blood cell (WBC) (\> 3,000/mm\^3) or absence of opportunistic infections (Turnstile II) * Require steroid therapy or steroid-containing compounds, or have used systemic steroids in the past 4 weeks, or have used topical or inhalational steroids in the past 2 weeks prior to lymphodepletion; the exception being patients on chronic physiologic dose of steroid (Turnstile II) * Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated (Turnstile II) * Patients who are solid organ transplant recipients * Patients with prior bone marrow or stem cell transplantation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.