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

Triumvira Immunologics, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Lymphoma, B-Cell

Interventions

TAC01-CD19BIOLOGICAL

Dose-escalating cohorts plus expansion groups

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of dose-limiting toxicities (DLTs)

Measurement of occurrence of study-defined DLTs

Time frame: First 28 days after dosing

Incidence of adverse events (AEs)

Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities

Time frame: Informed consent through 2 years after dosing

Data from ClinicalTrials.gov

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