Genetically Engineered Lymphocyte Therapy in Treating Patients With Lymphoma That is Resistant or Refractory to Chemotherapy

Exclusion Criteria

• •* Follicular lymphoma, previously identified as CD20+:
• •* At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy
• •* Stage III-IV disease
• •* Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year)
• •* Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
• •* CLL:
• •* Patients who achieve only a partial response to FCR as initial therapy will be eligible.
• •* Mantle cell lymphoma:
• •* Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc...)
• •* Relapsed after prior autologous SCT
• •* Diffuse large cell lymphoma, previously identified as CD20+:
• •* Relapsed after prior autologous SCT
• •* Expected survival \> 12 weeks
• •* Creatinine \< 2.5 mg/dl
• •* ALT/AST \< 3x normal
• •* Bilirubin \< 2.0 mg/dl
• •* Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy
• •* Adequate venous access for apheresis, and no other contraindications for leukapheresis
• •* Voluntary informed consent is given
• ••Pregnant or lactating women
• •* The safety of this therapy on unborn children is not known
• •* Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
• •* Uncontrolled active infection
• •* Active hepatitis B or hepatitis C infection
• •* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
• •* Previously treatment with any gene therapy products
• •* Feasibility assessment during screening demonstrates \< 30% transduction of target lymphocytes, or insufficient expansion (\< 5-fold) in response to CD3/CD28 costimulation
• •* Any uncontrolled active medical disorder that would preclude participation as outlined
• •* HIV infection