Title A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting CD19 in Relapsed or Refractory Large B-Cell Lymphoma
Protocole ID TAC01-CD19-01
ClinicalTrials.gov ID NCT03880279
Cancer Type(s) Non-Hodgkin's Lymphoma
Phase Phase I-II
Stage Refractory disease
Study Type Treatment
Drug Technologie TAC - TAC01-CD19
Institution CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
   PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
      5415 boul. de l'Assomption, MontrĂ©al, QC, H1T2M4
City
Principal Investigator Dr. Isabelle Fleury
Coordinator Michel-Olivier Gratton
514-252-3400 poste 2397
Status Recruiting
Activation Date
Eligibility 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.