CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Inclusion Criteria

• •Voluntarily sign informed consent form(s)
• •≥18 years of age at the time of signing informed consent
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)
• •Diagnosis of histologically or cytologically confirmed relapsed/refractory (R/R) Non Hodgkins lymphoma as defined as one of the following (Note: only patients with indolent lymphomas that warrant treatment should be treated, this will include those with local symptoms due to progressive/bulky disease, compromised organ function, B symptoms, extra-nodal disease, cytopenias from marrow involvement and/or in the opinion of the treating physician believe that any of the above symptoms or potentially life threatening involvement will occur will be treated):
• •1. Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a
• •1\. R/R disease after 2 or more prior lines of systemic therapy
• •2. Marginal Zone Lymphoma (MZL) nodal of extranodal:
• •1\. R/R disease after 2 or more prior lines of systemic therapy
• •3. Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and grade 3b Follicular Lymphoma (FL).
• •1. R/R disease after 2 or more prior lines of therapy OR
• •2. Relapsed following autologous SCT, OR
• •3. Ineligible for autologous SCT.
• •4. Mantle cell lymphoma
• •1. R/R disease as defined by disease progression after last regimen (including autologous SCT) OR
• •2. Refractory disease as defined as failure to achieve a CR to last regimen.
• •3. Prior therapy must include:
• •* Anthracycline or bendamustine-containing chemotherapy AND
• •* Anti-CD20 monoclonal antibody therapy AND
• •* BTKi therapy (progression does not have to be documented on BTKi).
• •Subjects must have measurable disease according to appropriate disease specific criteria.
• •Adequate absolute lymphocyte count (ALC \> 100 cells/ul) within one week of apheresis.
• •Adequate bone marrow function defined by absolute neutrophil count (ANC) \>1000 cells/mm3 without growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days) and untransfused platelet count \>50,000 mm3.
• •Left ventricular ejection fraction \> 40%
• •Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × upper limit of normal (ULN) and direct bilirubin \< 1.5 × ULN.
• •Adequate renal function defined by creatinine clearance \>60 ml/min using the Cockcroft-Gault formula.
• •The effects of CD79b-19 CAR T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis. Women of childbearing potential are required to use adequate contraception for up to 1 year post CD79b-19 CAR T cell infusion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 6 months after last CD79b-19 CAR T cells administration.
• •Ability and willingness to adhere to the study visit schedule and all protocol requirements
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)
• •No active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must have negative blood cultures x48 hours at time of cell infusion AND on appropriate broad spectrum antibiotic therapy
• •Oxygen saturation \>92% on room air while awake
• •No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing.
• •Infusion may be delayed by up to 5 days after completion of LD chemo, without sponsor approval, in the event that these issues resolve in that time frame.
• •The above criteria need to be met to start treatment (for both initiation of lymphodepletion and cell infusion).