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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 : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Biological: TAC01-CD19 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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 : June 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: TAC01-CD19
TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.
Biological: TAC01-CD19
Dose-escalating cohorts plus expansion groups




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: First 28 days after dosing ]
    Measurement of occurrence of study-defined DLTs

  2. 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.

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Responsible Party: Triumvira Immunologics, Inc.
ClinicalTrials.gov Identifier: NCT03880279     History of Changes
Other Study ID Numbers: TAC01-CD19-01
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin