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Trial record 5 of 5 for:    multitaa

TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (TACTIC)

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ClinicalTrials.gov Identifier: NCT03093350
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
National Cancer Institute (NCI)
Cancer Prevention Research Institute of Texas
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor College of Medicine

Brief Summary:

The study is being conducted in patients in which breast cancer has come back after standard treatment. Volunteers in this research study are treated using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.

The proteins that investigators are targeting in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, investigators target five common TAAs. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe.

Investigators now want to try this treatment in patients with breast cancer.

These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration.

The purpose of this study is to determine the clinical efficacy of TAA-specific CTLs, to learn what the side-effects are, and to see whether this therapy might help patients with breast cancer.


Condition or disease Intervention/treatment Phase
Breast Cancer Biological: TAA-specific CTLs Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Breast Cancer
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: TAA-Specific CTLs
Patients receiving TAA-specific CTLs as therapy for breast cancer.
Biological: TAA-specific CTLs

Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.

Dose schedule:

Day 0: 2 x 10^7 cells/m2

Day 28: 2 x 10^7 cells/m2

If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.





Primary Outcome Measures :
  1. The proportion of evaluable patients with complete response or partial response or stable disease for ≥10 weeks from the first infusion (6 weeks after the second infusion) according to the RECIST criteria [ Time Frame: 12 weeks ]
    To determine the clinical efficacy associated with the administration of multiTAA-specific T cells in breast cancer patients with metastatic or locally recurrent unresectable disease as measured by clinical benefit rate (defined as overall response plus stable disease for 10 weeks or longer) according to the RECIST criteria.


Secondary Outcome Measures :
  1. Median progression-free survival [ Time Frame: 12 weeks ]
    To evaluate the progression-free survival of patients after multiTAA-specific T cell infusion

  2. Median overall survival [ Time Frame: 12 weeks ]
    To evaluate the overall survival of patients after multiTAA-specific T cell infusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROCUREMENT INCLUSION CRITERIA:

  1. Any breast cancer patient with metastatic or locally recurrent unresectable disease.
  2. Patients with life expectancy greater than or equal to 12 weeks.
  3. Age greater than or equal to 18 and less than or equal to 80 years old.
  4. Hgb greater than 8.0.
  5. Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.

TREATMENT INCLUSION CRITERIA:

  1. Any breast cancer patient with metastatic or locally recurrent unresectable breast cancer currently progressive, after at least two prior lines of therapy in the advanced setting. Patients with HER2+ disease must have failed two or more different anti-HER2 agents.
  2. Patients must have measurable or evaluable disease per RECIST 1.1 criteria.
  3. Patients with life expectancy greater than or equal to 12 weeks.
  4. Age greater than or equal to 18 and less than or equal to 80 years old.
  5. Pulse oximetry of greater than 95% on room air.
  6. Patients with ECOG score less than or equal to 2 or a Karnofsky score of greater than or equal to 50.
  7. 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 greater than 8.0.
  8. Patients with a creatinine normal for age.
  9. Patients should have been off other investigational therapy for one month prior to receiving treatment on this study.
  10. Patients should have been off conventional therapy for at least 1 week prior to receiving treatment on this study.
  11. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion.
  12. Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.

PROCUREMENT EXCLUSION CRITERIA:

  1. Patients with severe intercurrent infection.
  2. Patients with active HIV infection at time of procurement.
  3. Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation.

TREATMENT EXCLUSION CRITERIA:

  1. Patients with severe intercurrent infection.
  2. Patients receiving systemic corticosteroids (Patients off steroids for at least 48 hours are eligible).
  3. Pregnant or lactating.
  4. Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation.
  5. HIV positive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093350


Contacts
Contact: Mothaffar F Rimawi, MD 713-798-1311 rimawi@bcm.tmc.edu
Contact: Catherine Robertson 832-824-4594 crobertson@txch.org

Locations
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Mothaffar Rimawi, MD    713-798-1311    rimawi@bcm.tmc.edu   
Contact: Catherine Robertson    832-824-4594    crobertson@txch.org   
Smith Clinic - Harris Health System Recruiting
Houston, Texas, United States, 77054
Contact: Mothaffar Rimawi    713-798-1311    rimawi@bcm.edu   
Contact: Jana Knezevic    713-798-1975    knezevic@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
National Cancer Institute (NCI)
Cancer Prevention Research Institute of Texas
Investigators
Principal Investigator: Mothaffar F Rimawi, MD Baylor College of Medicine
Principal Investigator: Anne Leen, PhD Baylor College of Medicine
Principal Investigator: Juan F Vera, MD Baylor College of Medicine

Responsible Party: Mothaffar Rimawi, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03093350     History of Changes
Other Study ID Numbers: H-39209 TACTIC
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mothaffar Rimawi, Baylor College of Medicine:
Breast Cancer
Tumor Associated Antigen Specific T cells

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases