TAA-Specific CTLS for Solid Tumors (TACTASOM)

NCT02239861 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: H-35425, TACTASOM
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Rhabdomyosarcoma; cytotoxic T lymphocytes

Outcome Measures

Primary Outcomes (1)

• Number of patients with dose-limiting toxicity.

  The Phase I dose escalation trial is designed for the primary goal of evaluating the safety and feasibility of administering TAA-CTLs to patients with solid tumors.

  8 weeks

Secondary Outcomes (1)

• Number of patients with a disease response to the CTLs.

  8 weeks

Study Arms (1)

TAA-Specific CTLs

EXPERIMENTAL

4 different dosing schedules will be evaluated. 2 to 4 patients will be evaluated on each dosing schedule. The first 2 patients on each dose level will be staggered by 4 weeks (which starts when the first infusion is given, Day 0). No subjects between the ages of 2-18 will be enrolled to a dose level on this protocol, until an adult has been enrolled to and treated on that dose level on one of the protocols being conducted under this same IND. Each patient will receive 2 injections at the same dose,14 days apart: The expected volume of infusion will be 1 to 10 cc. Dose Level One: Day 0 and 14: 5 x 10\^6 cells/m\^2 Dose Level Two: Day 0 and 14: 1 x 10\^7 cells/m\^2 Dose Level Three: Day 0 and 14: 2 x 10\^7 cells/m\^2 Dose Level Four: Day 0 and 14: 4 x 10\^7 cells/m\^2

Biological: TAA-Specific CTLs

Interventions

TAA-Specific CTLs BIOLOGICAL

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.

Also known as: Tumor Associated Antigen-Specific Cytotoxic T-Lymphocytes

TAA-Specific CTLs

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with:
• Active disease after first line therapy;
• Refractory disease;
• As adjuvant therapy for high risk disease (high risk disease is a disease that has a \>50% risk of progression within 5 years)
• Patients with life expectancy at least 6 weeks.
• Age greater than or equal to 2 and less than or equal to 80 years old.
• Hgb \>8.0
• Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

You may not qualify if:

• Diagnosis of primary CNS tumor.
• Patients with severe intercurrent infection.
• Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).
• Patients in remission who are enrolled on another study where time to progression or disease-free survival is a primary endpoint.
• Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with:
• Active disease after first line therapy;
• Refractory disease;
• As adjuvant therapy for high risk disease (high risk disease is a disease that has a \>50% risk of progression within 5 years)
• Patients with life expectancy at least 6 weeks.
• Age greater than or equal to 2 and less than or equal to 80 years old.
• Pulse oximetry of \>95% on room air in patients who previously received radiation therapy.
• Patients with a Karnofsky/Lansky score of greater than or equal to 50.
• Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, and Hgb \>8.0
• Patients with a creatinine less than or equal to 2x upper limit of normal for age.
• Patients should have been off other investigational therapy for one month prior to entry in this study.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator
• Solving Kids' Cancer: collaborator
• Pierce Phillips Charity: collaborator

Study Sites (2)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Rhabdomyosarcoma

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Ann Leen, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Cliona Rooney, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Helen Heslop, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Sarah Whittle, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Hematology/Oncology, Center for Cell and Gene Therapy

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: April 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: April 7, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

US (2)