huCART19-IL18-eDHFR Cells in Relapsed/Refractory Follicular Lymphoma

Inclusion Criteria

• •1. Signed informed consent form
• •2. Male or females age ≥ 18 years
• •3. Diagnosis of follicular lymphoma, grades 1-3A
• •4. Relapsed or refractory disease after at least 2 prior lines of systemic therapy as follows:
• •1. Prior therapy must include an anti-CD20 monoclonal or bispecific antibody and an alkylating agent.
• •2. Must have progressed within 2 years after second or higher line of therapy.
• •5. Documentation of CD19 expression on malignant cells by flow cytometry/IHC from a CLIA certified laboratory. Results must be within 6 months of physician-investigator confirmation of eligibility and after any intervening CD19 directed therapy since expression confirmed.
• •6. Patients with relapsed disease after prior allogeneic SCT must meet the following criteria:
• •1. Have no active GVHD and require no immunosuppression
• •2. Are more than 6 months from transplant at the time of physician-investigator confirmation of eligibility
• •7. Evidence of progressive disease within 12 weeks of physician-investigator confirmation of eligibility.
• •8. ECOG Performance Status that is either 0 or 1.
• •9. Adequate organ function defined as:
• •1. Serum creatinine ≤ 1.5x ULN or estimated creatinine clearance ≥ 35 mL/min and not on dialysis
• •2. ALT/AST ≤ 3 x ULN
• •3. Direct bilirubin ≤ 2.0 mg/dl; for patients with Gilbert's syndrome direct bilirubin must be ≤ 3.0 mg/dl
• •4. Left Ventricular Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
• •5. Must have minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air