Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma (TACTIC-19)
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ClinicalTrials.gov Identifier: NCT03880279 |
Recruitment Status :
Withdrawn
(Following a change in company governance, Triumvira terminated the study prior to enrolling any subjects due to a challenging competitive landscape.)
First Posted : March 19, 2019
Last Update Posted : February 23, 2022
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Sponsor:
Triumvira Immunologics, Inc.
Information provided by (Responsible Party):
Triumvira Immunologics, Inc.
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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.
Condition or disease | Intervention/treatment | Phase |
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Lymphoma, B-Cell | Biological: TAC01-CD19 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Estimated Study Start Date : | May 2020 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2024 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Lymphoma
Arm | Intervention/treatment |
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Experimental: TAC01-CD19
TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.
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Biological: TAC01-CD19
Dose-escalating cohorts plus expansion groups |
Primary Outcome Measures :
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
No Contacts or Locations Provided
Responsible Party: | Triumvira Immunologics, Inc. |
ClinicalTrials.gov Identifier: | NCT03880279 |
Other Study ID Numbers: |
TAC01-CD19-01 |
First Posted: | March 19, 2019 Key Record Dates |
Last Update Posted: | February 23, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Additional relevant MeSH terms:
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |