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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoma, B-Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAC01-CD19

TAC01-CD19, Autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.

Group Type EXPERIMENTAL

TAC01-CD19

Intervention Type BIOLOGICAL

Dose-escalating cohorts plus expansion groups

Interventions

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TAC01-CD19

Dose-escalating cohorts plus expansion groups

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No