MedTrace Logo

Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors

NCT05194735 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-11-10

Study results available
· View outcomes & findings →

Summary

A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory solid tumors

Conditions

Interventions

BIOLOGICAL

Neoantigen specific TCR-T cell drug product

Phase I: Ascending dose, single Infusion of TCR+ Cells Phase II: Single infusion at the RP2D

BIOLOGICAL

Aldesleukin (IL-2)

To support growth and activation of TCR-T cell drug product

Sponsors & Collaborators

  • Alaunos Therapeutics

    lead INDUSTRY

Principal Investigators

  • Scott Kopetz, MD, PhD · MD Anderson

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-04
Primary Completion
2023-08-14
Completion
2023-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05194735 on ClinicalTrials.gov