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TACTIC-19: Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma

Sponsor
Triumvira Immunologics, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03880279
Collaborator
(none)
0
Enrollment
1
Arm
47
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: TAC01-CD19
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
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
Anticipated Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of dose-limiting toxicities (DLTs) [First 28 days after dosing]

    Measurement of occurrence of study-defined DLTs

  2. Incidence of adverse events (AEs) [Informed consent through 2 years after dosing]

    Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Triumvira Immunologics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Triumvira Immunologics, Inc.
ClinicalTrials.gov Identifier:
NCT03880279
Other Study ID Numbers:
  • TAC01-CD19-01
First Posted:
Mar 19, 2019
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Feb 23, 2022