A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting CD19 in Relapsed or Refractory Large B-Cell Lymphoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Triumvira Immunologics, Inc.
- Primary Endpoint
- Incidence of dose-limiting toxicities (DLTs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
TAC01-CD19
TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.
Intervention: TAC01-CD19 (Biological)
Outcomes
Primary Outcomes
Incidence of dose-limiting toxicities (DLTs)
Time Frame: First 28 days after dosing
Measurement of occurrence of study-defined DLTs
Incidence of adverse events (AEs)
Time Frame: Informed consent through 2 years after dosing
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities
Secondary Outcomes
No secondary outcomes reported