A Phase 1/2 interventional study of Cyclophosphamide and Decitabine in Advanced Fallopian Tube Carcinoma, Advanced Malignant Solid Neoplasm and Advanced Melanoma, sponsored by Roswell Park Cancer Institute. Active, not recruiting at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Roswell Park Cancer Institute · Phase 1/2, Interventional, and Treatment
This phase I/IIa trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced). A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Placing a modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then giving them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving gene-modified T cells with or without decitabine works better in treating patients with malignancies expressing NY-ESO-1.
PRIMARY OBJECTIVE:
I. To evaluate the safety and feasibility of adoptive transfer of TGFbDNRII-transduced autologous tumor infiltrating lymphocytes (autologous NY-ESO-1 TCR/dnTGFbetaRII transgenic T cells).
SECONDARY OBJECTIVES:
I. NY-ESO-1 TCR/ dnTGFbetaRII transgenic T cell persistence by analyzing serial peripheral blood samples for the presence of T cells with the NY-ESO-1 TCR by tetramer analysis.
II. To study T cell differentiation that correlates with higher anti-tumor responses.
III. To test the hypothesis that NY-ESO-1 TCR/dnTGFbetaRII will constitute in cells more efficient in inducing tumor regression.
IV. Determine objective tumor responses by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1.
EXPLORATORY OBJECTIVE:
I. To evaluate the role of microbiota on the therapeutic efficacy of the proposed therapy.
OUTLINE: This is a phase I, dose-escalation study of NY-ESO-1 TCR/TGFbDNRII-transduced TILs followed by a phase IIa study. Participants are assigned 1 to 2 cohorts.
COHORT I: Patients undergo leukapheresis on day -6, and receive cyclophosphamide intravenously (IV) over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
COHORT II: Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
After completion of study treatment, patients are followed up at weeks 1-4, 6, 8, and 12, at 6 and 9 months, every 6 months for 5 years, and then yearly for 10 years.
834 studies on the registry are indexed under Fallopian Tube Neoplasms; 130 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 683 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Patients with solid tumors as described below:
Inoperable or (advanced) melanoma:
Inoperable or metastatic (advanced) ovarian, primary peritoneal or fallopian tube carcinoma:
Inoperable or metastatic (advanced) synovial sarcoma:
Subjects with other histologies:
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
A minimum of one defined as:
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:
Exclusion Criteria:
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.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
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.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Drug: Cyclophosphamide · Other: Laboratory Biomarker Analysis · Procedure: Leukapheresis · Biological: TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed.
Drug: Cyclophosphamide · Drug: Decitabine · Other: Laboratory Biomarker Analysis · Procedure: Leukapheresis · Biological: TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes
Given IV
Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719
Given IV
Also known as: 5-Aza-2''-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine
Correlative studies
Undergo leukapheresis
Also known as: Leukocytopheresis, Therapeutic Leukopheresis
Given IV
Also known as: TGFbDNRII-transduced Autologous TILs
Number of Participants With Dose Limiting Toxicities
Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.
Time frame: Up to 30 days
Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells
Unfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration. The count of patients not meeting the preparation criteria are reported.
Time frame: 1 month
Expression of the NY-ESO-1 T Cell Receptor (TCR) Transgenic Protein in Peripheral Blood Mononuclear Cells (PBMC)
TCR and vector presence will be quantitated in PBMC samples, obtained before adoptive transfer and at weeks 1, 2, 4, 8, and 12 after transgenic cell adoptive transfer. Thereafter, sampling will be every 3 months during the first year, and then every 6 to 12 months per schedule of procedures and observations.
Time frame: Up to 15 years
Replication Competent Retrovirus (RCR)
Will be assessed in blood by polymerase chain reaction (PCR).
Time frame: Up to 1 year
Tumor Response (Complete and Partial Response)
Will be determined by immune-related Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response assessment will be performed by comparing standard computed tomography imaging scans and photographs of target lesions from baseline.
Time frame: Up to 90 days after TCR transgenic PBMC adoptive transfer
| Milestone | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 6 |
| Completed | 3 | 3 | 3 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
Will be assessed using Common Toxicity Criteria. Patients will be monitored by medical histories, physical examinations, ophthalmologic exams, and blood studies to detect potential toxicities from the treatment. the number of patients experiencing a DLT are reported.
| Participants | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) |
|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities | 0 | 0 | 0 | 0 |
Unfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration. The count of patients not meeting the preparation criteria are reported.
| Participants | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) |
|---|---|---|---|---|
| Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells | 0 | 1 | 0 | 0 |
TCR and vector presence will be quantitated in PBMC samples, obtained before adoptive transfer and at weeks 1, 2, 4, 8, and 12 after transgenic cell adoptive transfer. Thereafter, sampling will be every 3 months during the first year, and then every 6 to 12 months per schedule of procedures and observations.
Results for this outcome have not been posted.
Will be assessed in blood by polymerase chain reaction (PCR).
Results for this outcome have not been posted.
Will be determined by immune-related Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response assessment will be performed by comparing standard computed tomography imaging scans and photographs of target lesions from baseline.
Results for this outcome have not been posted.
Collected over Adverse events were captured during treatment and up to 30 days post treatment. Based on the observed data, the AE time frame was from 1.1 to 22.3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | 1/3 (33.3%) | 2/3 (66.7%) | 3/3 (100%) |
| Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | 1/3 (33.3%) | 3/3 (100%) | 3/3 (100%) |
| Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 2/3 (66.7%) | 1/3 (33.3%) | 3/3 (100%) |
| Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 4/6 (66.7%) | 3/6 (50%) | 6/6 (100%) |
| Event | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) |
|---|---|---|---|---|
| Cytokine release syndromeImmune system disorders | 0/3 | 3/3 | 0/3 | 1/6 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/3 | 2/3 | 0/3 | 0/6 |
| Eye painEye disorders | 0/3 | 0/3 | 1/3 | 0/6 |
| NauseaGastrointestinal disorders | 0/3 | 0/3 | 1/3 | 0/6 |
| AstheniaGeneral disorders | 0/3 | 0/3 | 1/3 | 0/6 |
| ChillsGeneral disorders | 1/3 | 0/3 | 0/3 | 0/6 |
| FatigueGeneral disorders | 0/3 | 0/3 | 1/3 | 0/6 |
| CellulitisInfections and infestations | 1/3 | 0/3 | 0/3 | 0/6 |
| InfectionInfections and infestations | 0/3 | 1/3 | 0/3 | 0/6 |
| RhinitisInfections and infestations | 0/3 | 1/3 | 0/3 | 0/6 |
| Event | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 3/3 | 1/3 | 2/3 | 4/5 |
| VomitingGastrointestinal disorders | 2/3 | 3/3 | 2/3 | 1/5 |
| FatigueGeneral disorders | 3/3 | 2/3 | 2/3 | 1/5 |
| Oedema peripheralGeneral disorders | 3/3 | 2/3 | 1/3 | 0/5 |
| White blood cell count decreasedInvestigations | 3/3 | 2/3 | 0/3 | 3/5 |
| ConstipationGastrointestinal disorders | 0/3 | 0/3 | 2/3 | 1/5 |
| DiarrhoeaGastrointestinal disorders | 1/3 | 0/3 | 2/3 | 1/5 |
| NauseaGastrointestinal disorders | 1/3 | 2/3 | 2/3 | 3/5 |
| PyrexiaGeneral disorders | 0/3 | 0/3 | 2/3 | 2/5 |
| Neutrophil count decreasedInvestigations | 2/3 | 1/3 | 0/3 | 2/5 |
| Age, Categorical(Participants) | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 1 | 1 |
| Between 18 and 65 years | 2 | 3 | 3 | 5 | 13 |
| >=65 years | 1 | 0 | 0 | 0 | 1 |
| Age, Continuous(Year) | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Total |
|---|---|---|---|---|---|
| Mean | 62.2 ± 8.3 | 61.4 ± 2.0 | 60.1 ± 2.7 | 43.8 ± 18.4 | 54.3 ± 14.5 |
| Sex: Female, Male(Participants) | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Total |
|---|---|---|---|---|---|
| Female | 2 | 3 | 1 | 2 | 8 |
| Male | 1 | 0 | 2 | 4 | 7 |
| Race (NIH/OMB)(Participants) | Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 1 | 1 |
| White | 3 | 3 | 3 | 2 | 11 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 3 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2017 to primary completion in Mar 2021, 43 months.
Results were first posted in May 2022, 1 year 2 months after primary completion.
Of 37 phase 1/2 interventional studies under Fallopian Tube Neoplasms, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 56 and three quarters within 110. This study's 43 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Decitabine
Roswell Park Cancer Institute →