University of Maryland, Baltimore
The goal of this study is to treat patients diagnosed with relapsed or refractory positive B cell lymphoma - positive for 2 or more target antigens - with CAR19.20.22 CAR T-cells. Based on the preclinical characteristics of the LTG2950, CAR19.20.22 tri-specific CAR T-cells the Investigators have developed the following hypotheses to be tested in our phase Ia clinical trial. The Investigators hypothesize that these novel CAR T-cells will show: * good safety and tolerability * a high degree of efficacy * very good persistence * an acceptable level of exhaustion
This is a phase 1a, open-label, single center study evaluating the safety and efficacy CAR19.20.22 in subjects with r/r B-cell malignancies. The study will comprise dose-escalation. The dose-escalation will use a modified 3+3 design. Up to 12 subjects will be enrolled and treated at the sequential dose-escalation levels and evaluated. Infusion of CAR19.20.22 will be staggered to allow observations of acute and subacute toxicities.
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed relapsed/refractory B cell Lymphoma. Histologies allowed: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), Follicular Lymphoma (FL), transformed follicular lymphoma (tFL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Richter's transformation with or without concurrent CLL, Burkitt's lymphoma. * Relapsed or Refractory disease after two lines or more of therapy (except one or more line for MCL) including rituxi…
CAR19.20.22 is a type of immunotherapy known as a chimeric antigen receptor T-cells (CAR T-cells).
Lymphodepletion with Flu-Cy prior to CAR T cell therapy