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Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03880279

Acronym

TACTIC-19

Enrollment

Registered

2019-03-19

Start date

2020-05-31

Completion date

2024-04-30

Last updated

2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, B-Cell

Brief 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.

Interventions

BIOLOGICALTAC01-CD19

Dose-escalating cohorts plus expansion groups

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of dose-limiting toxicities (DLTs)	First 28 days after dosing	Measurement of occurrence of study-defined DLTs
Incidence of adverse events (AEs)	Informed consent through 2 years after dosing	Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026