Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
Phase 1
Withdrawn
- Conditions
- Lymphoma, B-Cell
- Interventions
- Biological: TAC01-CD19
- Registration Number
- NCT03880279
- Lead Sponsor
- Triumvira Immunologics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAC01-CD19 TAC01-CD19 TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method