Breast CancerPhase 2TACTICNCT03093350
TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer
A Phase 2 study testing TAA-specific CTLs in people with Breast Cancer, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TAA-specific CTLs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2017to 23 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
PROCUREMENT INCLUSION CRITERIA:
- Any breast cancer patient with metastatic or locally recurrent unresectable disease.
- Patients with life expectancy greater than or equal to 12 weeks.
- Age greater than or equal to 18 and less than or equal to 80 years old.
- Hgb greater than or equal to 7.0.
- Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
TREATMENT INCLUSION CRITERIA:
- 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.
- Patients must have measurable or evaluable disease per RECIST 1.1 criteria.
- Patients with life expectancy greater than or equal to 12 weeks.
- Age greater than or equal to 18 and less than or equal to 80 years old.
- Pulse oximetry of greater than 95% on room air.
- Patients with ECOG score less than or equal to 2 or a Karnofsky 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 greater than or equal to 7.0.
- Patients with a creatinine normal for age.
- Patients should have been off other investigational therapy for one month prior to receiving treatment on this study.
- Patients should have been off conventional therapy for at least 1 week prior to receiving treatment on this study.
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion.
- Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
PROCUREMENT EXCLUSION CRITERIA:
- Patients with severe intercurrent infection.
- Patients with active HIV infection at time of procurement.
- Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation.
TREATMENT EXCLUSION CRITERIA:
- Patients with severe intercurrent infection.
- Patients receiving systemic corticosteroids (Patients off steroids for at least 48 hours are eligible).
- Pregnant or lactating.
- Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation.
- HIV positive.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Smith Clinic - Harris Health System
Houston, Texas, 77054
About this study
Official title: Tumor Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Breast Cancer
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.
Read more
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.
Read the detailed description
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
Investigators will take a maximum of approximately 79 teaspoons of blood from patients on one to three occasions over a two-month period. Under certain conditions related to the patient's health, blood may be collected using a process called apheresis. Apheresis is the process where blood is passed through a machine that separates out the components of blood that we need. The remainder of the patient's blood will then be returned to his/her body.
Investigators will use this blood to grow T cells. Investigators will first grow a special type of cells called dendritic cells which will activate T cells. Once these are made, investigators will load them with small pieces of protein called peptides taken from the TAAs that we want to target. This helps train the T cells to kill cancer cells which express TAAs on their surface. Then the TAA-specific CTLs are expanded.
The cells will be infused by intravenous infusion (IV) into the patient over 1-10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the TAA-CTL administration. Initially, two doses of TAA-CTLs will be given four weeks apart. The patient's cancer will be assessed pre-infusion, and then 6 weeks after the second infusion. If after the second infusion there is a reduction in the size of the patient's tumor on Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET) as assessed by a radiologist, the patient can receive up to six (6) additional doses of the TAA-CTLs if they wish. At least one month should pass before each additional dose. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital.
In between the first and second TAA-CTL infusions, and for 6 weeks after the 2nd infusion, the patient should not receive any other anti-cancer treatments such as radiation therapy or chemotherapy. If the patient does receive any other therapies in-between the first and second infusion of TAA-CTLs, they will be taken off treatment and will not be able to receive the second infusion.
MEDICAL TESTS BEFORE TREATMENT:
Before being treated, patients will receive a series of standard medical tests:
- Physical exam.
- Blood tests to measure blood cells, kidney and liver function.
- Measurements of the patient's tumor by routine imaging studies.
- Pregnancy test if the patient is a female who can have children.
MEDICAL TESTS DURING TREATMENT:
Patients will receive standard medical tests on the day of their second and subsequent infusions:
- Physical exam
- Blood tests to measure blood cells, kidney and liver function.
MEDICAL TESTS AFTER TREATMENT
- Imaging study 6 weeks after the 2nd TAA-CTL infusion.
To learn more about the way the TAA-CTLs are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each infusion, at Weeks 1, 2, and 4 after the first cell dose and at Weeks 1, 2, 4 and 6 after the second cell dose. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the 2nd infusion. Investigators will use this blood to see how long the TAA-CTLs last, and to look at the patient's immune system response to the cancer. The immune system is part of the body that helps protect against disease.
Study Duration: The patient's active participation in this study will last for approximately one (1) year. If the patient receives additional doses of the TAA-CTLs as described above, his/her active participation will last until one (1) year after the last dose. Investigators will then contact the patient once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate the patient's disease response long-term.
- Conditions
- Breast Cancer
- Being tested
- TAA-specific CTLs
- Keywords
- Breast Cancer, Tumor Associated Antigen Specific T cells
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAA-specific CTLsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| TAA-Specific CTLs | Experimental | Patients receiving TAA-specific CTLs as therapy for breast cancer. Receives: Biological: TAA-specific CTLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 12 weeks
Secondary outcomes (2)
Median Progression-free Survival
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.
Measured: 1 year
Median Overall Survival
To evaluate the overall survival of patients after multiTAA-specific T cell infusion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start10 Oct 2017
- Primary completion30 May 2019
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine, National Cancer Institute (NCI), Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, Mothaffar Rimawi, Baylor College of Medicine
- Investigators
- Mothaffar F Rimawi, MD, Principal investigator, Baylor College of MedicineAnne Leen, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093350
- Sponsor's protocol ID
- H-39209 TACTIC
- Other IDs
- P50CA186784
- Acronym
- TACTIC
- Status last verified
- Aug 2025
- First submitted
- 22 Mar 2017
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT03093350
- Acronym / sponsor ID
- TACTIC / H-39209 TACTIC
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Tumor Associated Antigen Specific T cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine, National Cancer Institute (NCI), Cancer Prevention Research Institute of Texas
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
Investigators will take a maximum of approximately 79 teaspoons of blood from patients on one to three occasions over a two-month period. Under certain conditions related to the patient's health, blood may be collected using a process called apheresis. Apheresis is the process where blood is passed through a machine that separates out the components of blood that we need. The remainder of the patient's blood will then be returned to his/her body.
Investigators will use this blood to grow T cells. Investigators will first grow a special type of cells called dendritic cells which will activate T cells. Once these are made, investigators will load them with small pieces of protein called peptides taken from the TAAs that we want to target. This helps train the T cells to kill cancer cells which express TAAs on their surface. Then the TAA-specific CTLs are expanded.
The cells will be infused by intravenous infusion (IV) into the patient over 1-10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the TAA-CTL administration. Initially, two doses of TAA-CTLs will be given four weeks apart. The patient's cancer will be assessed pre-infusion, and then 6 weeks after the second infusion. If after the second infusion there is a reduction in the size of the patient's tumor on Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET) as assessed by a radiologist, the patient can receive up to six (6) additional doses of the TAA-CTLs if they wish. At least one month should pass before each additional dose. All of the treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital.
In between the first and second TAA-CTL infusions, and for 6 weeks after the 2nd infusion, the patient should not receive any other anti-cancer treatments such as radiation therapy or chemotherapy. If the patient does receive any other therapies in-between the first and second infusion of TAA-CTLs, they will be taken off treatment and will not be able to receive the second infusion.
MEDICAL TESTS BEFORE TREATMENT:
Before being treated, patients will receive a series of standard medical tests:
- Physical exam.
- Blood tests to measure blood cells, kidney and liver function.
- Measurements of the patient's tumor by routine imaging studies.
- Pregnancy test if the patient is a female who can have children.
MEDICAL TESTS DURING TREATMENT:
Patients will receive standard medical tests on the day of their second and subsequent infusions:
- Physical exam
- Blood tests to measure blood cells, kidney and liver function.
MEDICAL TESTS AFTER TREATMENT
- Imaging study 6 weeks after the 2nd TAA-CTL infusion.
To learn more about the way the TAA-CTLs are working in the patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before each infusion, at Weeks 1, 2, and 4 after the first cell dose and at Weeks 1, 2, 4 and 6 after the second cell dose. Afterwards, blood will be collected at 3, 6, 9 and 12 months after the 2nd infusion. Investigators will use this blood to see how long the TAA-CTLs last, and to look at the patient's immune system response to the cancer. The immune system is part of the body that helps protect against disease.
Study Duration: The patient's active participation in this study will last for approximately one (1) year. If the patient receives additional doses of the TAA-CTLs as described above, his/her active participation will last until one (1) year after the last dose. Investigators will then contact the patient once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate the patient's disease response long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAA-Specific CTLs | Experimental | Biological: TAA-specific CTLsPatients receiving TAA-specific CTLs as therapy for breast cancer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAA-specific CTLsEach 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. | Biological | TAA-Specific CTLs |
Primary outcome
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.
2 secondary outcomes
Median Progression-free Survival
Time frame: 1 year
Median Overall Survival
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mothaffar F Rimawi, MD principal investigator
Baylor College of Medicine
Anne Leen, PhD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAA-specific CTLs in people with Breast Cancer, run by Baylor College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.