Anti-CD19-ARTEMIS T Cells, Fludarabine Phosphate, and Cyclophosphamide in Treating Participants with CD19+ Relapsed or Refractory Non-Hodgkin's Lymphoma

Inclusion Criteria

• Subjects with relapsed/refractory CD19+ non-Hodgkin’s lymphoma of the following subtypes: * Diffuse large B-cell lymphoma (DLBCL) * Mantle cell lymphoma (MCL) * Follicular lymphoma (FL) * Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) * Burkitt’s Lymphoma
• Ability to provide written informed consent for the protocol
• Willingness and ability to comply with scheduled visit, treatment plans, laboratory tests, and other procedures
• Eastern Cooperative Oncology Group performance status of =< 2
• Evidence of at least one measurable lesion on imaging with the following exceptions * Subjects treated with interim chemotherapy for disease control between enrollment verification and ET190L1-ARTEMIS T cell infusion who do not have measurable disease at re-screening are still eligible * CLL/SLL with documented B-cell absolute lymphocytosis > 5 x 10^9 cells/L peripheral blood or infiltration of lymph nodes and/or bone marrow infiltration by CLL phenotype cells defined as clonal B cells with majority population co-expressing CD5 and CD19, with surface immunoglobulin (sIg, kappa or lambda but not both) and CD20 (dim), CD23+ (if CD20 or sIg are bright or if CD23 is dim or negative [atypical CLL phenotype] then fluorescence in situ hybridization (FISH) for 11:14 translocation must be performed to differentiate from mantle cell lymphoma) * Lesions previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy ** Measurable lesions are nodes/nodal masses > 1.5 cm, extranodal masses > 1.0 cm or positron emission tomography (PET) avid lesions consistent with lymphoma
• Must have biopsy-proven primary refractory disease or relapsed disease and meet at least one of the following: * For subjects with DLBCL: relapsed or refractory disease after >= 2 prior line(s) of therapy; for both de novo and transformed disease, patients must have received at least 1 prior regimen with anti-CD20 monoclonal antibody (mAb) and anthracycline (anthracycline used for the prior low grade disease also would satisfy this requirement) * For subjects with FL or SLL: relapsed or refractory disease after >= 2 prior line(s) of therapy * For subjects with CLL: must be relapsed or refractory disease and ** With no unfavorable cytogenetics and have failed >= 3 prior line(s) of therapy ** With unfavorable cytogenetics including del17p/mutated p53 or unmutated immunoglobulin heavy chain variable region relapsed or refractory disease after >= 2 prior line(s) of therapy which must have included ibrutinib * For subjects with MCL: relapsed or refractory disease after at least 1 prior regimen with chemoimmunotherapy * For subjects with Burkitt’s: relapsed or refractory disease after at least 1 prior line of therapy * Any subject, with subtypes listed above, having either failed autologous hematopoietic stem cell transplantation (HSCT) after at least 1 prior regimen, or those subjects ineligible for, but not an appropriate candidate, or not consenting to autologous HSCT
• Creatinine clearance >= 45ml/min
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3x the institutional upper limit of normal (ULN), except for people with liver involvement by their lymphoma, who may be included if AST/ALT =< 5x the institutional ULN
• Total bilirubin =< 2x the institutional ULN with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is =< 3.0x ULN and direct bilirubin is =< 2x ULN
• Must have a minimum level of pulmonary reserve defined as =< grade 1 dyspnea and pulse oximetry of >= 88% on room air
• Must be hemodynamically stable at the time of ET190L1-ARTEMIS T cell administration and have left ventricular ejection fraction (LVEF) >= 45% confirmed by echocardiogram or multigated acquisition scan (MUGA) scan
• Absolute neutrophil count (ANC) >= 1,000/mm^3
• Absolute lymphocyte count (ALC) >= 300/mm^3, and absolute number of CD3+ T cells > 150/mm^3
• Platelets >= 50,000/mm^3
• Hemoglobin >= 8 g/dL
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, and all male participants must use effective methods of contraception for at least 12 months following infusion of ET190L1-ARTEMIS T cells and ET190L1-ARTEMIS T cells are no longer present by PCR (with surveillance to cease at 5 years) * Highly effective contraception may change depending on current Institutional Review Board (IRB) standards but currently include ** Total abstinence, excluded are periodic abstinence utilizing the calendar, ovulation, symptothermal, or post-ovulation methods, or withdrawal technique ** Female sterilization including: 1) surgical bilateral oophorectomy with or without hysterectomy; in the case of oophorectomy alone when the reproductive status has been confirmed by follow up hormone level assessment and, 2) tubal ligation at least six weeks before taking study treatment ** Male sterilization at least 6 months prior to screening; in the case of female subjects with a male partner who has had a vasectomy, this partner should be the sole partner for that subject ** Contraception requiring consistent use of BOTH forms listed below must be utilized *** Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%) for example hormonal vaginal ring or transdermal hormonal contraception; women on oral contraception should be stable on the hormone pill for at least 3 months prior to infusion of study drug *** Barrier method of contraception to include: condom, occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/vaginal suppository *** Sexually active males must use a condom during intercourse for 12 months after treatment as they should not father a child in this period; a condom is required to be used by vasectomized men (as well as during intercourse with a male partner)

Exclusion Criteria

• Prior treatment * With any prior anti-CD19/anti-CD19 CAR-T or cellular therapy (prior blinatumomab therapy is allowed) * Treatment with any prior gene therapy * Prior allogeneic hematopoietic stem cell transplant * Received chemotherapy, radiation or surgical resection of malignancy within 2 weeks prior to the start of lymphodepleting chemotherapy (day -10 to -5)
• Active, uncontrolled serious infection or medical or psychiatric illness, that in the investigator’s opinion is likely to interfere with participation in this clinical trial
• Active central nervous system (CNS) involvement by malignancy
• History of seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
• Active replication of hepatitis B or active hepatitis C (hepatitis C virus [HCV] ribonucleic acid [RNA] positive); those with prior disease who are PCR negative at enrollment and meet liver function eligibility criterion are eligible
• Known human immunodeficiency virus (HIV) positive patients
• Patients with unstable angina and/or myocardial infarction within 6 months prior to screening
• Cardiac arrhythmia not controlled with medical management, evidence of pericardial effusion on imaging that is compromising function
• Previous or concurrent malignancy with exception of adequately treated basal cell or squamous cell carcinoma, in-situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to study drug infusion, or prostate cancer that was treated with prostatectomy or radiotherapy over 2 years before day 1 of protocol therapy and patients whose prostate-specific antigen (PSA) is undetectable at study entry
• Autoimmune disease or history of primary immunodeficiency (excluding Hashimoto’s thyroiditis, vitiligo, or diabetes mellitus [DM] type I)
• Women who are pregnant or breast feeding