Other Clinical Trial - BATs in Patients With Breast Cancer &

Status Terminated

Clinical Trial Summary

This study uses bi-specific antibody (HER2Bi) armed activated T-cells (HER2 BATs) to target breast cancer cells that have metastasized to the membranes surrounding the brain and spinal cord. This is known as leptomeningeal metastases. Two doses will be evaluated in order to determine a safe dose. Study treatment includes a test dose of HER2 BATs followed by 8 weekly infusions of HER2 BATs at the assigned dose level. Before, during and after study treatment, participants will be monitored objectively by brain MRIs and clinically through physical and neurological exams, and blood and cerebrospinal fluid will be collected to evaluate immune responses.

Clinical Trial Description

Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure approximately 3 to 4 weeks prior to the first BATs infusion. The white blood cells, specifically T cells, are then mixed with two proteins in order to activate the cells to multiply. After approximately 14 days in culture, the activated T cells are coated with OKT3 and trastuzumab/Herceptin (HER2Bi), and washed to remove excess Herceptin in order to produce bispecific antibody armed T cells (BATs). Cells are then frozen and stored until scheduled to be infused. Up to 2 weeks following leukapheresis, participants will undergo surgery to place the catheter/reservoir into the lateral ventricle of the brain to allow intraventricular administration of HER2 BATs and a chemotherapy agent methotrexate. A few weeks later, participants will receive the intraventricular methotrexate in order to control disease while the BATs product is being manufactured. About 4-5 weeks following the leukapheresis and at least 7 days after receiving methotrexate, study treatment will begin with a test dose of HER2 BATs. If this dose is well tolerated by the participant, she will then receive 8 weekly doses of HER2 BATs at the assigned dose level. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03661424
Study type	Interventional
Source	University of Virginia
Contact
Status	Terminated
Phase	Phase 1
Start date	February 26, 2019
Completion date	December 14, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03080623` - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed	`NCT05527769` - Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Completed	`NCT06376578` - Exercise Interventions for Improving Health in Breast Cancer Survivors	N/A
Completed	`NCT03004534` - A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide	Early Phase 1
Recruiting	`NCT05020574` - Microbiome and Association With Implant Infections	Phase 2
Active, not recruiting	`NCT06277141` - The Vitality Mammography Messaging Study	N/A
Completed	`NCT03555227` - USG PECS vs LIA for Breast Cancer Surgery	N/A
Completed	`NCT03270111` - High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women	N/A
Active, not recruiting	`NCT03917082` - Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer	Phase 2
Recruiting	`NCT05561842` - Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
Completed	`NCT04554056` - Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF	Phase 2/Phase 3
Active, not recruiting	`NCT03127995` - Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence	N/A
Active, not recruiting	`NCT02237469` - Prone Breast Radiotherapy Treatment Planning Observational Study
Completed	`NCT01204125` - Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients	Phase 2
Recruiting	`NCT04565054` - Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC	Phase 3
Not yet recruiting	`NCT06412133` - Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients	N/A
Recruiting	`NCT03956641` - Evolution of the Physical Condition in Treated Cancer Patients	N/A
Recruiting	`NCT06087120` - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting	`NCT06058936` - Exercises Using Virtual Reality on Cancer Patients	N/A
Completed	`NCT03470935` - Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

BATs in Patients With Breast Cancer and Leptomeningeal Metastases

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms