Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT04091295
Eligibility Criteria:
Inclusion Criteria:
* Patient is ≥12 years of age, either male or female for patients with sarcoma; \>18 years of age, either male or female.with pancreatic cancer or carcinoma of breast.
* Patient has pancreatic cancer or sarcoma or carcinoma of breast confirmed by pathologic examination at diagnosis.
* Patients with advanced metastatic pancreatic cancer who have received systemic therapies such as FOLFIRINOX and gemcitabine + albumin-bound paclitaxel; patients with metastatic sarcoma who have disease progression after two or more lines of systemic treatments and not amenable to surgical resection or radiotherapy; specifically for osteosarcoma: have disease progression after high dose methotrexate, cisplatinum, doxorubicin and ifosfamide; for soft tissue sarcoma: have disease progression after doxorubicin + ifosfamide/mesna, gemcitabine, docetaxel, dacarbazine, trabectedin, pazopanib, eribulin; patients with metastatic carcinoma of breast who have disease progression with standard therapy (ACT), targeted therapies including aromatase inhibitors, trastuzumab, pertuzumab, enhertu, tyrosine kinase inhibitors, immune checkpoint inhibitors; patient who is intolerant to or declines available therapeutic options after documentation that patient has been informed of the available therapeutic options.
* Patient is able to understand or is willing to sign a written informed consent.
* Patient agrees to use barrier contraception during vector infusion period and for 6 weeks after infusion
Exclusion Criteria:
* Patient is unwilling to provide formal informed consent.
* Patient is unwilling to use barrier contraception during vector infusion period and for 6 weeks after infusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
100 Years
Study:
NCT04091295
Study Brief:
Protocol Section:
NCT04091295