TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (TACTIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03093350|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : January 23, 2018
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)|
|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|
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.
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.
- 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.
- Median progression-free survival [ Time Frame: 12 weeks ]To evaluate the progression-free survival of patients after multiTAA-specific T cell infusion
- Median overall survival [ Time Frame: 12 weeks ]To evaluate the overall survival of patients after multiTAA-specific T cell infusion
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
|Contact: Mothaffar F Rimawi, MDfirstname.lastname@example.org|
|Contact: Catherine Robertsonemail@example.com|
|United States, Texas|
|Houston Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Mothaffar Rimawi, MD 713-798-1311 firstname.lastname@example.org|
|Contact: Catherine Robertson 832-824-4594 email@example.com|
|Smith Clinic - Harris Health System||Recruiting|
|Houston, Texas, United States, 77054|
|Contact: Mothaffar Rimawi 713-798-1311 firstname.lastname@example.org|
|Contact: Jana Knezevic 713-798-1975 email@example.com|
|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|