TAA-Specific CTLS for Solid Tumors (TACTASOM)

Summary

This is a clinical trial for patients with a solid tumor which has come back, or may come back, or has not gone away after treatment, including the standard treatment we know for these diseases. This is a study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.

The proteins that the investigators are targeting in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells. In this study, the investigators target five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different study, patients have been treated and so far this treatment has shown to be safe.

The investigators now want to try this treatment in patients with solid tumors.

This protocol is designed as a Phase I dose-escalation study.

Conditions

• Rhabdomyosarcoma

Interventions

BIOLOGICAL

TAA-Specific CTLs

Patients may be pre-medicated with Benadryl up to 1 mg/kg IV (max 50 mg) and Tylenol 10 mg/kg po (max 650 mg). Cell Administration: Tumor-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line. Patients with stable disease or better will receive up to 6 further doses of CTLs, as long as they continue to show disease stabilization or improvement by RECIST criteria at their 8 week or subsequent evaluations. Each dose will consist of the same number as their second injection or less (if there is not enough product available for the subject's original dose). Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  collaborator OTHER

• Center for Cell and Gene Therapy, Baylor College of Medicine

  collaborator OTHER

• Solving Kids' Cancer

  collaborator OTHER

• Pierce Phillips Charity

  collaborator UNKNOWN

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Ann Leen, PhD · Baylor College of Medicine

• Cliona Rooney, PhD · Baylor College of Medicine

• Helen Heslop, MD · Baylor College of Medicine

• Sarah Whittle, MD · Baylor College of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2018-10-31

Completion

2022-04-07

FDA Drug

Yes

Countries

• United States

Study Locations