Study Stopped
Following a change in company governance, Triumvira terminated the study prior to enrolling any subjects due to a challenging competitive landscape.
Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
TACTIC-19
A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting CD19 in Relapsed or Refractory Large B-Cell Lymphoma
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2020
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedFebruary 23, 2022
February 1, 2022
1.9 years
March 13, 2019
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of dose-limiting toxicities (DLTs)
Measurement of occurrence of study-defined DLTs
First 28 days after dosing
Incidence of adverse events (AEs)
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities
Informed consent through 2 years after dosing
Study Arms (1)
TAC01-CD19
EXPERIMENTALTAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2019
First Posted
March 19, 2019
Study Start
May 1, 2020
Primary Completion
April 1, 2022
Study Completion
April 1, 2024
Last Updated
February 23, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share