Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant

Korábbi kezelés

• ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of screening;
• Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings). The principal investigator is the final arbiter of this criterion;
• Subjects of reproductive potential unwilling to use effective forms of birth control or abstinence for a year after transplantation;

Más betegség

• Active CNS involvement by malignant cells;
• Positive HIV serology or viral RNA
• Bovine product allergy

Laborértékek

• Pregnancy (positive serum βHCG test) or breast-feeding;

• Subjects aged \>18yrs and \< 65yrs
• Clinical diagnosis of one of the following adult hematological malignancies
  • Leukemia
  • Myelodysplastic Syndromes
  • Lymphomas
  • Multiple myeloma
  • Other high-risk hematologic malignancies eligible for stem cell transplantation per institutional standard Life expectancy \>10 weeks
• Evidence of recurrent disease that presents \> 100 days or minimal residual disease (MRD) that presents \> 30 days after one of the following:
  • Matched related HSCT
  • Mismatched related HSCT
• Signed patient informed consent;
• A minimum genotypic identical match of 4/8 is required, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1
• Performance status: Karnofsky score \> 50%
• Subjects with adequate organ function as measured by:
  • Bone marrow:
  • \> 25% donor T-cell chimerism
  • ANC \>1 x 10E9/L
  • Cardiac: left ventricular ejection fraction at rest must be \>45%.
  • Hepatic: direct bilirubin ≤ 3 x upper limit of normal, or AST/ALT ≤ 5 x upper limit of normal
  • Renal: creatinine ≤ 2x of ULN for age
  • Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) \> 50% predicted (corrected for hemoglobin)