A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T Cells in HLA-A2+ Patients With Synovial Sarcoma

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase ITreatment4 to 55ADP 04511
NCI-2015-00410, NCI-2013-01481, UPCC 04511, NCT01343043

Trial Description


The purpose of this early (pilot) clinical trial is to test the effects (both good and bad)

of chemotherapy and the NYESO T cells on patients with metastatic and recurrent synovial


Further Study Information


Patients will undergo apheresis at the enrolling institution. Fresh PBMC will be

shipped to University of Pennsylvania and shipped back to the enrolling institution.

Patients will undergo lymphodepletion with denileukin diftitox, fludarabine and

cyclophosphamide, then infusion of NY-ESO-1 genetically engineered T cells on Day 0.

Patients will be monitored for toxicity, antitumor effects and immune endpoints.

Patients with a PR or SD may receive a 2nd cycle no earlier than 60 days following

completion of the first cycle if eligibility criteria are met. For patients with

progressive disease, a 2nd cycle that includes high dose aldesleukin administered

beginning on the day of T cell infusion may be administered no earlier than 60 days

following completion of the first cycle if eligibility criteria are met.

Eligibility Criteria

Inclusion Criteria:

Female and male patients (and when relevant their partners) must be willing to

practice birth control (including abstinence) during and for two months after


Ability to give informed consent for patients greater than 18 years of age. For

patients less than 18 years of age the legal guardian must give informed consent.

Age-adjusted normal serum creatinine or a creatinine clearance greater than or equal

to 60 ml/min/1.73m2

Platelets > 75,000/mm3

ANC > 750/mm3

AST, ALT less than or equal to 2.5 x upper limit of normal

T.bilirubin < 2 mg/dl (Patients with Gilbert Syndrome exempt)

Left ventricular ejection fraction greater than or equal to 40% or fractional

shortening greater than or equal to 28%

Life expectancy greater than 3 months

Performance Status. ECOG 0, 1 or 2 for age greater than 10 years. Lansky greater

than or equal to 60 for children less than or equal to 10 years of age.

Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved

to grade 2 or less

All previous cytotoxic chemotherapy, monoclonal antibody therapy, immune, biologic or

molecularly targeted therapy must be completed at least 3 weeks prior to study entry.

Weigh more than 18 kg

Age 4 to less than or equal to 55. NIH 4 to less or equal to 35. Washington

University greater than or equal to 18.


Synovial sarcoma and NY-ESO-1+ expression by immunohistochemistry

Measurable disease

Synovial sarcoma that has been treated with standard chemotherapy containing

doxorubicin and remains: unresectable or metastatic or progressive/persistent or

recurrent disease

Exclusion Criteria:

Patients who require systemic corticosteroid or other immunosuppressive therapy.

Immunosuppressive therapy must be stopped at least 14 days prior to cell infusion.

Active HIV, HBV or HCV infection

Lactating or pregnant females

Previous treatment with genetically engineered NY-ESO-1 specific T cells. Previous

vaccine therapy is not an exclusion criteria.

Untreated CNS metastasis

Clinically significant systemic illness that in the judgment of the PI would

compromise the patient's ability to tolerate protocol therapy or significantly

increase the risk of complications.

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Adaptimmune Limited

  • National Cancer Institute

Trial Sites



Mark O Hatfield-Warren Grant Magnuson Clinical Center

Crystal L. Mackall
Ph: 301-402-5940
Email: cm35c@nih.gov

Crystal L. Mackall
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01343043

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.