Engineered immune cells take aim at Hard-to-Treat cancers

NCT ID NCT02650986

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial investigates a new type of immunotherapy for people with advanced cancers that carry a specific marker called NY-ESO-1. Researchers take a patient's own T cells, modify them in the lab to better recognize and attack cancer cells, and then infuse them back. The study also tests whether adding a chemotherapy drug called decitabine can make the modified T cells work better. The goal is to find the safest dose and see if this approach can shrink tumors or slow the disease.

What this could mean

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

Active substance
gene-modified T cells targeting NY-ESO-1 with TGFβ blockade
What this could lead to
If successful, this approach could offer a new treatment option for people with advanced cancers that express NY-ESO-1, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply broadly. There are risks of side effects from the modified T cells and chemotherapy, and the treatment may not work for everyone.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

15 people

The number who actually took part.

Started

Jul 2017

Expected to finish

Jul 2032

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 years and older

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 with solid tumors as described below: * Inoperable or metastatic (advanced) melanoma: * Has received, is intolerant, or refused a CTLA-4 inhibitor (ipilimumab) or a PD-1 inhibitor (nivolumab or pembrolizumab) as monotherapy and/or a combination of ipilimumab and nivolumab * Has received or is intolerant of a BRAF inhibitor or the combination of BRAF and MEK inhibitors for BRAFv600 mutant melanoma and a PD-1 inhibitor as monotherapy or in combination * Inoperable or metastatic (advanced) ovarian, primary peritoneal or fallopian tube carcinoma: * Has received platinum containing chemotherapy and has platinum refractory or resistant disease that has progressed on second line therapy * If platinum sensitive disease, should have received \>= 2 lines of chemotherapy * May have received PARP inhibitors, bevacizumab or other targeted VEGF inhibitor therapy * Inoperable or metastatic (advanced) synovial sarcoma: * Should have received and progressed on \>= two lines of systemic therapy * Subjects with other histologies: * Must have previously received two lines of systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been deemed either non-responders (progressive disease) or have recurred * For cohorts 1, 2 and 3 only: Patient's tumor must be positive by histological or molecular assay for NY-ESO-1, according to the screening algorithm; historical results may be used * For cohort 4, NY-ESO-1 results will be noted but NY-ESO-1 positivity is not required for eligibility * Human leukocyte antigen (HLA)-A\*0201 (HLA-A2.1) positivity by molecular subtyping (blood test or buccal swab, historical documentation acceptable) * Age \>= 18 years old, (Cohort 4: Age \>= 12 years old) * Life expectancy greater than 3 months assessed by a study physician * Have been informed of other treatment options * A minimum of one measurable lesion defined as: * Meeting the criteria for measurable disease according to irRECIST criteria * For patients with skin metastases, lesions selected as non-completely biopsied target lesion(s) that can be accurately measured and recorded by color photography with a ruler to document the size of the target lesion(s) * No restriction based on prior treatments but at least 4 weeks from prior immunotherapy, or prior investigational agents. Note: Patients who have suffered \>grade 2 irAEs during previous checkpoint inhibitor therapy should be excluded. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Must have adequate venous access for apheresis * Women of childbearing potential and men must agree to use effective methods of birth control for the duration of the study and 6 months after; methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used * Leukocytes: \>= 3,000/mcl * Absolute neutrophil count: \>= 1,000/mcl * Platelets: \>= 100,000/mcl * Total bilirubin: =\< 1.5 upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]): =\< 2.5 x institutional upper limit of normal * Creatinine: =\< 2 X ULN; if creatinine \> 2 X ULN, creatinine clearance must be \> 60 ml/min * Must be willing and able to accept the leukapheresis procedure * At screening, must have tissue available for NY-ESO-1 testing (if not previously performed) or be willing and able to undergo a fresh tissue biopsy * Patient must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure * Participant must agree to and arrange for a caregiver (age \>= 18 years old) available 24 hours a day/ 7 days a week and arrange for lodging within 45 minutes drive to Roswell Park and transportation for a period of time after discharge from the hospital; the exact amount of time will depend on the individual status as determined by the treating physician * ELIGIBILITY CRITERIA FOR A SECOND TRANSGENIC T CELL INFUSION Subjects in whom disease control was observed after the T cell infusion may be eligible for a second transgenic T cell infusion if the subject meets the following criteria: * Patient attained confirmed disease control (either complete remission \[CR\], partial remission \[PR\] or stable disease \[SD\]) after the first transgenic T cell infusion * Patient still meets the eligibility criteria above * A second T cell infusion is discussed and the patient agrees to receive it * Either cryopreserved extra cells from the first T cell product is available or cryopreserved autologous peripheral blood mononuclear cell (PBMC) is available for the manufacture of a second transgenic T cell product Exclusion Criteria: * Previously known hypersensitivity to any of the agents used in this study * Currently receiving any other investigational agents. Note: Patients who have suffered \>grade 2 irAEs during previous checkpoint inhibitor therapy should be excluded. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; electrocardiogram (EKG) will be done at screening; cardiac stress test will be done as clinically indicated, the specific test to be chosen at the discretion of the treating physician. * History of severe autoimmune disease requiring steroids or other immunosuppressive treatments * History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, which in the investigator's opinion would place the patient at an increased risk for adverse effect or current acute colitis of any origin; treated cases with no active disease are eligible * Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment (inhaled or topical steroids at standard doses or isolated use of steroids as premedication for medical procedures to minimize allergic reaction \[e.g. computed tomography (CT) scan dye\] are allowed) * Known active infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C or cytomegalovirus (CMV) * Known cases of clinically active brain metastases (brain magnetic resonance imaging \[MRI\] as clinically indicated); prior evidence of brain metastasis successfully treated with surgery or radiation therapy will not be exclusion for participation as long as they are deemed under control at the time of study enrollment * Dementia or significantly altered mental status that would prohibit the understanding or rendering of compliance with the requirements of this protocol even with caregiver support * Pregnancy or breast-feeding; female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and 6 months after; all female patients with reproductive potential must have a negative pregnancy test (serum/urine) within 48 hours from starting the conditioning chemotherapy * Lack of availability of a patient for immunological and clinical follow-up assessment

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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.

Advanced fallopian tube carcinoma Advanced malignant solid neoplasm Advanced melanoma Advanced ovarian carcinoma Advanced primary peritoneal carcinoma Advanced synovial sarcoma Clinical stage III cutaneous melanoma ajcc V8 Clinical stage IV cutaneous melanoma ajcc V8 Metastatic fallopian tube carcinoma Metastatic melanoma Metastatic ovarian carcinoma Metastatic primary peritoneal carcinoma Metastatic synovial sarcoma Pathologic stage III cutaneous melanoma ajcc V8 Pathologic stage IIIA cutaneous melanoma ajcc V8 Pathologic stage IIIB cutaneous melanoma ajcc V8 Pathologic stage IIIC cutaneous melanoma ajcc V8 Pathologic stage iiid cutaneous melanoma ajcc V8 Pathologic stage IV cutaneous melanoma ajcc V8 Platinum-resistant fallopian tube carcinoma Platinum-resistant ovarian carcinoma Platinum-resistant primary peritoneal carcinoma Stage III fallopian tube cancer ajcc V8 Stage III ovarian cancer ajcc V8 Stage III primary peritoneal cancer ajcc V8 Stage IIIA fallopian tube cancer ajcc V8 Stage IIIA ovarian cancer ajcc V8 Stage IIIA primary peritoneal cancer ajcc V8 Stage IIIA1 fallopian tube cancer ajcc V8 Stage IIIA1 ovarian cancer ajcc V8 Stage IIIA2 fallopian tube cancer ajcc V8 Stage IIIA2 ovarian cancer ajcc V8 Stage IIIB fallopian tube cancer ajcc V8 Stage IIIB ovarian cancer ajcc V8 Stage IIIB primary peritoneal cancer ajcc V8 Stage IIIC fallopian tube cancer ajcc V8 Stage IIIC ovarian cancer ajcc V8 Stage IIIC primary peritoneal cancer ajcc V8 Stage IV fallopian tube cancer ajcc V8 Stage IV ovarian cancer ajcc V8 Stage IV primary peritoneal cancer ajcc V8 Stage IVA fallopian tube cancer ajcc V8 Stage IVA ovarian cancer ajcc V8 Stage IVA primary peritoneal cancer ajcc V8 Stage IVB fallopian tube cancer ajcc V8 Stage IVB ovarian cancer ajcc V8 Stage IVB primary peritoneal cancer ajcc V8 Unresectable melanoma Unresectable ovarian carcinoma Unresectable synovial sarcoma

Contacts and locations

Locations

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

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