Back to resultsAutologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma (TACTIC-19)
Primary Purpose
Lymphoma, B-Cell
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TAC01-CD19
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-Cell
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAC01-CD19
Arm Description
TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.
Outcomes
Primary Outcome Measures
Incidence of dose-limiting toxicities (DLTs)
Measurement of occurrence of study-defined DLTs
Incidence of adverse events (AEs)
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities
Secondary Outcome Measures
Full Information
NCT ID
NCT03880279
First Posted
March 13, 2019
Last Updated
February 7, 2022
Sponsor
Triumvira Immunologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03880279
Brief Title
Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Following a change in company governance, Triumvira terminated the study prior to enrolling any subjects due to a challenging competitive landscape.
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Triumvira Immunologics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAC01-CD19
Arm Type
Experimental
Arm Description
TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.
Intervention Type
Biological
Intervention Name(s)
TAC01-CD19
Intervention Description
Dose-escalating cohorts plus expansion groups
Primary Outcome Measure Information:
Title
Incidence of dose-limiting toxicities (DLTs)
Description
Measurement of occurrence of study-defined DLTs
Time Frame
First 28 days after dosing
Title
Incidence of adverse events (AEs)
Description
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities
Time Frame
Informed consent through 2 years after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
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