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Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes | Clinical Trials | Clareo Health

TERMINATEDEARLY_PHASE1

Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes

Pilot Study of Adoptive Cell Transfer for the Treatment of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes

NCT02774291•Albert Einstein College of Medicine

View on ClinicalTrials.gov

Summary

This pilot clinical trial studies the side effects of anti-ESO (cancer/test antigen) murine T-cell receptor (mTCR)-transduced autologous peripheral blood lymphocytes and combination chemotherapy with cyclophosphamide and fludarabine phosphate in treating patients with cancer that has spread to other places in the body (metastatic) and expresses the gene NY-ESO-1. Donor white blood cells that are treated in the laboratory with anti-cluster of differentiation (CD)3 may help treat metastatic cancer. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Aldesleukin may stimulate white blood cells, including natural killer cells, to kill metastatic cancer cells. Giving anti-ESO (cancer/test antigen) mTCR-transduced autologous peripheral blood lymphocytes together with combination chemotherapy and aldesleukin may kill more cancer cells.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of the administration of anti-ESO (cancer/test antigen) mTCR (T cell receptor)-engineered peripheral blood lymphocytes (anti-thyroglobulin mTCR-transduced autologous peripheral blood lymphocytes) plus high-dose aldesleukin following a nonmyeloablative lymphoid depleting preparative regimen in human leukocyte antigen (HLA)-A2 positive patients with metastatic cancer expressing the ESO antigen. SECONDARY OBJECTIVES: I. Determine the in vivo survival of T-cell receptor (TCR) gene-engineered cells. II. Determine the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. OUTLINE: Patients receive standard cyclophosphamide intravenously (IV) over 1 hour on days -7 to -6 and fludarabine phosphate via intravenous piggy back (IVPB) over 30 minutes on days -5 to -1 followed by anti-ESO (cancer/test antigen) mTCR-transduced autologous peripheral blood lymphocytes IV over 20-30 minutes on day 0 and aldesleukin IV over 15 minutes approximately every 8 hours on days 0-4. Patients also receive filgrastim subcutaneously (SC) on days 1-4. After completion of study treatment, patients are followed up at 6 weeks, annually for 5 years, and then periodically for 10 years thereafter.

Eligibility

Age

18 - 66 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Measurable metastatic cancer that expresses NY ESO-1 as assessed by one of the following methods: reverse transcriptase-polymerase chain reaction (RT-PCR) on tumor tissue, or by immunohistochemistry of resected tissue, or serum antibody reactive with ESO
•Confirmation of diagnosis of metastatic cancer by the Laboratory of Pathology at the Montefiore Medical Center
•Patients must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
•3 or fewer brain metastases; Note: if lesions are symptomatic or greater than or equal to 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible
•More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo); Note: patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria
•Eight weeks must have elapsed from the time of any antibody therapy that could affect an anti-cancer immune response, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA 4) therapy, at the time the patient receives the preparative regimen to allow antibody levels to decline; Note: patients who have previously received ipilimumab and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsies
•Willing to sign a durable power of attorney
•Able to understand and sign the informed consent document
•Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1
•Life expectancy of greater than three months
+13 more criteria

Exclusion Criteria

•Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
•Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
•Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease
•Concurrent opportunistic infections (the experimental treatment being evaluated in this protocol depends on an intact immune system; patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities)
•Concurrent systemic steroid therapy
•History of severe immediate hypersensitivity reaction to any of the agents used in this study
•History of coronary revascularization or ischemic symptoms
•History of or active central nervous system (CNS) or peripheral nerve stimulation (PNS) involvement
•Documented left ventricular ejection fraction (LVEF) of less than or equal to 45%; testing is required in patients with:
•* Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
+4 more criteria

Locations (1)

Albert Einstein College of Medicine

The Bronx, New York, United States

Key Dates

Start Date

April 20, 2017

Primary Completion Date

July 1, 2020

Completion Date

August 4, 2020

Last Updated

August 4, 2023

Enrollment

ACTUAL participants

Conditions

HLA-A2 Positive Cells PresentMetastatic Malignant NeoplasmMetastatic Malignant Neoplasm in the Brain

Interventions

Aldesleukin

BIOLOGICAL

Anti-thyroglobulin mTCR-transduced Autologous Peripheral Blood Lymphocytes

BIOLOGICAL

Cyclophosphamide

DRUG

Filgrastim

BIOLOGICAL

Fludarabine Phosphate

DRUG

Laboratory Biomarker Analysis

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes

Inclusion Criteria

Exclusion Criteria

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