TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer

NCT03093350 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: H-39209 TACTICP50CA186784
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Tumor Associated Antigen Specific T cells

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (2)

• Median Progression-free Survival

  1 year

• Median Overall Survival

  1 year

Study Arms (1)

TAA-Specific CTLs

EXPERIMENTAL

Patients receiving TAA-specific CTLs as therapy for breast cancer.

Biological: TAA-specific CTLs

Interventions

TAA-specific CTLs BIOLOGICAL

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.

TAA-Specific CTLs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator
• National Cancer Institute (NCI): collaborator
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (2)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Smith Clinic - Harris Health System

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Shaun Bulsara
• Organization: Baylor College of Medicine

sbulsara@bcm.edu

713-798-8014

Study Officials

• Mothaffar F Rimawi, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Anne Leen, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: October 10, 2017
• Primary Completion: May 30, 2019
• Study Completion: August 23, 2024
• Last Updated: August 29, 2025
• Results First Posted: April 29, 2020

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)