To determine the safety, toxicity, and maximum tolerated dose (MTD) of CD19/CD20 bispecific CAR-T cells with 4-1BB and mutated CD28 costimulatory domains (20-19 Tan BB06z) in patients with relapsed or refractory CD19+ aggressive hematologic malignancies
To be eligible for leukapheresis, patients must have an aggressive CD19+ B cell malignancy with relapsed or refractory disease, defined as below.
To be eligible for treatment with 20-19 Tan BB06z CAR-T cells, patients must additionally have detectable evidence of residual malignancy at the time of assessment prior to CAR-T cell infusion, regardless of therapy administered following leukapheresis.
Relapsed or refractory DLBCL/HGBL following 2 or more prior chemoimmunotherapy regimens containing an anthracycline and CD20-directed therapy following diagnosis of de novo DLBCL/HGBL or DLBCL arising from indolent lymphoma.
Relapse following a single prior chemoimmunotherapy regimen containing an anthracycline and CD20-directed therapy following diagnosis of de novo DLBCL/HGBL or DLBCL arising from indolent lymphoma and considered ineligible for high dose chemotherapy and autologous stem cell rescue as determined by the investigator.
Pregnant or lactating patients.
Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan during screening.
Patients with active known autoimmune disease requiring systemic T cell suppressive therapy are ineligible.
Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T cell suppressive therapy are ineligible.
Single group
20-19 Tan BB06oz CAR T
Biological/VaccineThis investigational product is a genetically modified chimeric antigen receptor t-cell product expressing a biospecific anti CD19/CD20 and incorporating both 4-1BB and mutated CD28 costimulatory domains.
Maximum Tolerated Dose (MDT)
MTD will be established from Dose limiting toxicities after infusion
Event Free Survival
Time from Car-T cell infusion to disease progression, relapse or death from anycause,w hichever occured first. EFS will be assessed by using the Kaplan-Meier method.
Overall Survival
Date of infusion until death. OS will be assessed using the Kaplan-Meier method
persistence of modified T-cells
Duration of T-cell persistence will be estimated using flow cytometry in peripheral blood and bone marrow.
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