Trial Search Results

A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma

The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and adoptive immunotherapy with T cells engineered to recognize NY-ESO-1 peptide in patients with unresectable, metastatic or recurrent synovial sarcoma.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Adaptimmune

Stanford Investigator(s):

Intervention(s):

  • Biological: NY-ESO-1(c259)T Cells

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Synovial sarcoma that has been treated with standard chemotherapy containing
   ifosfamide and/or doxorubicin and remains: unresectable or metastatic or
   progressive/persistent or recurrent disease

   - Measurable disease

   - Patients must have proven positive tumor sample for NY-ESO-1 as follows:

      - Cohort 1 -Positive expression is defined as 2+ and/or 3+ by immunohistochemistry
      in ≥ 50% of cells.

      - Cohort 2 -Positive expression is defined as ≥1+ by immunohistochemistry in ≥1%
      cells, but not to exceed 2+ and/or 3+ in ≥ 50% of cells.

      - Cohort 3 -Positive expression is defined as 2+ and/or 3+ by immunohistochemistry
      in ≥ 50% of cells.

      - Cohort 4 -Positive expression is defined as 2+ and/or 3+ by immunohistochemistry
      in ≥ 50% of cells.

   - HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 by high resolution testing at a local or
   central laboratory

   - Weigh more than 18 kg

   - All previous cytotoxic chemotherapy, monoclonal antibody therapy, or immune therapy
   must be washed out 3 weeks before apheresis and must be completed at least 3 weeks
   prior to pre-infusion lymphodepletive chemotherapy.

   - Systemic corticosteroid or other immunosuppressive therapy should be washed out 2
   weeks before apheresis and must be completed at least 2 weeks prior to pre-infusion
   lymphodepletive chemotherapy.

   - Biologic or other approved molecular targeted small molecule inhibitors should be
   washed out 1 week or 5 half-lives (whichever is longer) before apheresis and must be
   completed at least 1 week or 5 half-lives (whichever is longer) prior to pre-infusion
   lymphodepletive chemotherapy.

   - Any grade 3 or 4 hematologic toxicity of any previous therapy must have resolved to
   grade 2 or less prior to apheresis and any grade 3 or 4 toxicity must have resolved to
   grade 2 or less prior to pre-infusion lymphodepletive chemotherapy.

   - ECOG 0-1, or for children ≤10 years of age, Lansky > 60

   - Life expectancy > 3 months

   - Left ventricular ejection fraction ≥ 40% or fractional shortening ≥ 28%

   - T. bilirubin < 2 mg/dl (Patients with Gilbert Syndrome total bilirubin <3xULN and
   direct bilirubin ≤ 35%)

   - AST, ALT ≤ 2.5 x upper limit of normal

   - ANC ≥ 1.0 x 10⁹/L

   - Platelets ≥ 75 x 10⁹/L

   - Age-adjusted normal serum creatinine or a creatinine clearance ≥ 40 ml/min

   - 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.

   - Male patients must be willing to practice birth control (including abstinence) during
   and for 4 months after treatment. Female patients must be willing to practice birth
   control (including abstinence) during treatment and for 4 months after gene modified
   cells are no longer detected in body.

Exclusion Criteria:

   - Active HIV, HBV, HCV or HTLV 1/2 infection (due to increased risk of complications
   during lymphodepleting regimen and confounding effects on the immune system). Active
   hepatitis B or C infection is defined by seropositive for hepatitis B surface antigen
   (HbSAg) or hepatitis C antibody.

Ages Eligible for Study

4 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting