A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T Cells in HLA-A2+ Patients With Synovial Sarcoma
Basic Trial Information
|Phase I||Treatment||4 to 55||ADP 04511|
NCI-2015-00410, NCI-2013-01481, UPCC 04511, NCT01343043
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.
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
Synovial sarcoma that has been treated with standard chemotherapy containing
doxorubicin and remains: unresectable or metastatic or progressive/persistent or
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
- National Cancer Institute
Mark O Hatfield-Warren Grant Magnuson Clinical Center
Crystal L. Mackall
Crystal L. Mackall
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.