Phase 2
N=12
TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03093350 ↗Enrolled (actual)
12
Serious AEs
10.0%
Results posted
Apr 2020
Primary outcome: Primary: 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 — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAA-specific CTLs (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1 | — |
| SECONDARY Median Progression-free Survival |
69.5 | — |
| SECONDARY Median Overall Survival |
116 | — |
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 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03093350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.