TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (TACTIC)
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|ClinicalTrials.gov Identifier: NCT03093350|
Recruitment Status : Active, not recruiting
First Posted : March 28, 2017
Results First Posted : April 29, 2020
Last Update Posted : June 4, 2020
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 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|
|Actual Primary Completion Date :||May 30, 2019|
|Estimated Study Completion Date :||May 30, 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 Number 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). Per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Overall Response (OR) = CR + PR.
- Median Progression-free Survival [ Time Frame: 1 year ]To evaluate the progression-free survival of patients after multiTAA-specific T cell infusion. Progression is defined, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Criteria, as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Median Overall Survival [ Time Frame: 1 year ]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
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Smith Clinic - Harris Health System|
|Houston, Texas, United States, 77054|
|Principal Investigator:||Mothaffar F Rimawi, MD||Baylor College of Medicine|
|Principal Investigator:||Anne Leen, PhD||Baylor College of Medicine|