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NCT04323657 · ClinicalTrials.gov registry record · Phase 1

TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia

A Phase 1 study of Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by TCR2 Therapeutics.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target
3
Study locations

NCT04323657 is a Phase 1 study of Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma that has completed, run by TCR2 Therapeutics. The registered enrollment target is 6 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT04323657, a Phase 1 study of Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma, has completed, sponsored by TCR2 Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target
3
Study locations

Study Summary

TC-110 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human CD19, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex. This is a Phase 1/2 open-label study to evaluate the safety of autologous genetically engineered TC-110 T cells in patients with aggressive NHL (DLBCL, PMBCL, TFL), high-risk indolent NHL (including MCL), or adult ALL.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG TC-110 T Cells

Study Locations (3)

Colorado

  • Colorado Blood Cancer Institute - Denver

Tennessee

  • Sarah Cannon Research Institute - Nashville

Texas

  • University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2020-03-27
Est. Completion 2023-02-24
Phase Phase 1

Sponsor

TCR2 Therapeutics

3 total trials

What the Registry Record Tells You About NCT04323657

The ClinicalTrials.gov registry entry for NCT04323657 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (98% lower). The listed sponsor is TCR2 Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.

NCT04323657 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Colorado, Tennessee, Texas.

Frequently Asked Questions

What is clinical trial NCT04323657 about?

NCT04323657 is a clinical study titled "TC-110 T Cells in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma or Acute Lymphoblastic Leukemia". TC-110 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human CD19, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex. This is a Ph...

What is the current status of trial NCT04323657?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-03-27. Estimated completion is 2023-02-24.

What conditions does trial NCT04323657 study?

This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma.

What interventions are being tested in trial NCT04323657?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), TC-110 T Cells (DRUG).

Who is sponsoring clinical trial NCT04323657?

This trial is sponsored by TCR2 Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04323657 being conducted?

This trial has 3 study locations across Colorado, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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