NCT03880279

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

A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting CD19 in Relapsed or Refractory Large B-Cell Lymphoma

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Triumvira Immunologics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
BIOLOGICAL	TAC01-CD19	Dose-escalating cohorts plus expansion groups

Timeline

• Start date: 2020-05-01
• Primary completion: 2022-04-01
• Completion: 2024-04-01
• First posted: 2019-03-19
• Last updated: 2022-02-23

Regulatory

• FDA-regulated drug study