Clinical Trials /

Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma

NCT03880279

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Double-Hit Lymphoma
  • Mediastinal Large B-Cell Lymphoma
  • Transformed Lymphoma
  • Triple-Hit Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: TAC01-CD19-01
  • NCT ID: NCT03880279

Conditions

  • Lymphoma, B-Cell

Interventions

DrugSynonymsArms
TAC01-CD19TAC01-CD19

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TAC01-CD19ExperimentalTAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.
  • TAC01-CD19

Eligibility Criteria

        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.

          -  Measurable disease per Cheson Criteria 2014 at time of enrollment.

          -  Adequate organ function.

        Exclusion Criteria:

          -  High disease burden.

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

          -  Monoclonal antibody within 4 weeks or chemotherapy within 2 weeks
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose-limiting toxicities (DLTs)
Time Frame:First 28 days after dosing
Safety Issue:
Description:Measurement of occurrence of study-defined DLTs

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Triumvira Immunologics, Inc.

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