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

Lymphoma, B-Cell Clinical Trial

— TACTIC-19  

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03880279
• Other study ID #: TAC01-CD19-01
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: May 2020
• Est. completion date: April 2024

Study information

• Verified date: February 2022
• Source: Triumvira Immunologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2024
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• TAC01-CD19
Dose-escalating cohorts plus expansion groups

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Triumvira Immunologics, Inc.

Outcome

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