Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
Phase I/II study to evaluate TAC01-CD19 in subjects with relapsed or refractory B-cell
 lymphomas. TAC technology is a novel way to genetically modify T cells and to redirect these
 T cells to target cancer antigens by co-opting the natural T cell receptor. The dose finding
 portion of this study will evaluate the safety and tolerability of increasing dose levels of
 TAC01-CD19 to identify a Maximal Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D).
 The dose expansion portion of the study will further evaluate the safety, efficacy and
 pharmacokinetics of TAC01-CD19 at the RP2D.
Inclusion Criteria:

 -  Histologically confirmed CD19+ Large B-Cell Lymphoma including Diffuse Large B-cell
 Lymphoma (DLBCL) not otherwise specified (including de novo and transformed lymphoma),
 Primary Mediastinal Large B-cell Lymphoma, High-Grade B-cell Lymphoma with MYC and
 BCL2 and/or BCL6 rearrangement per WHO 2016 classification.

 -  Relapsed or refractory disease after greater than 2 lines of therapy including
 anthracycline and anti-CD20 therapy and either having failed autologous stem cell
 transplant (ASCT) or being ineligible for ASCT.

 -  ECOG 0-1.

 -  Adequate organ function.

 Exclusion Criteria:

 -  Prior treatment with any of the following: allogeneic bone marrow transplantation,
 gene therapy, adoptive cell transfer of any kind, including CAR T cells.

 -  Active central nervous system (CNS) lymphoma involvement.

 -  History or presence of clinically relevant CNS pathology.

 -  Active inflammatory neurological disorders, autoimmune disease, or infections.