Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.

Korábbi kezelés

• Concurrent use of systemic steroids or chronic use of immunosuppressant medications.

Más betegség

• CLL patients with known or suspected transformed disease (i.e. Richter's transformation).
• Uncontrolled active infection.
• Active hepatitis B or hepatitis C infection.
• Any uncontrolled active medical disorder
• HIV infection.
• Patients with active CNS involvement with malignancy.
• Class III/IV cardiovascular disability according to the New York Heart Association Classification.
• Subjects with clinically apparent arrhythmia or arrhythmias who are not stable

Egyéb

• Pregnant or lactating women.

• Documented CD19+ CLL or SLL
• Patients must have failed at least 1 prior regimen
• Patients must be currently receiving ibrutinib for at least 3 months prior to enrollment in the study and:
• Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
• ECOG Performance status 0 or 1
• 18 years of age and older
• Adequate organ system function including:
  • Creatinine < 1.6 mg/dl ALT/AST < 3x upper limit of normal Total Bilirubin <2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.
• Have no active GVHD and require no immunosuppression
• Are more than 6 months from transplant
• No contraindications for leukapheresis
• Left Ventricular Ejection fraction >50%
• Gives informed consent