Description:
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.
Title
- Brief Title: Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
- 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 IDs
- ORG STUDY ID:
TAC01-CD19-01
- NCT ID:
NCT03880279
Conditions
Interventions
Drug | Synonyms | Arms |
---|
TAC01-CD19 | | TAC01-CD19 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
TAC01-CD19 | Experimental | TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels. | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of dose-limiting toxicities (DLTs) |
Time Frame: | First 28 days after dosing |
Safety Issue: | |
Description: | Measurement of occurrence of study-defined DLTs |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Triumvira Immunologics, Inc. |
Last Updated
March 27, 2020