A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer (NCT04137536) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
United States7 participantsStarted 2019-10-17
Plain-language summary
The purpose of this study is to find the safest dose and identify any bad side effects of EGFR-BATs (bispecific antibody-armed activated T cells) for people with advanced pancreatic cancer who have already received first-line standard chemotherapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic pancreatic cancer who have received at least first line chemotherapy. Disease stability or progression during or within 6 months after treatment with 5-Fluorouracil (5-FU)- or gemcitabine-based chemotherapy. KPS\>/= 70% or SWOG performance Status 0 or 1
* Evaluable disease by iRECIST criteria
* Absolute Neutrophil Count (ANC) \>/= 1,000/mm\^3
* Lymphocyte count \>/= 400/mm\^3
* Platelet Count \>/= 75,000/mm\^3
* Hemoglobin \>/= 8 g/dL
* Serum Creatinine \< 2.0 mg/dl, Creatinine Clearance \>/=50 ml/mm (can be calculated or measured)
* Total Bilirubin \</= 2 mg/dl (biliary stent is allowed)
* SGPT and SGOT \<5.0 times normal
* LVEF \>/= 55% at rest (\<UGA or Echo)
* Age \>/= 18 years at the time of consent (Written informed consent and HIPAA authorization for release of personal health information)
* Females of childbearing potential, and males, must be willing to use an effective method of contraception
* Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
Exclusion Criteria:
* Any chemotherapy related toxicities from prior treatment, \> grade 2 per CTCAE v4.0
* Known hypersensitivity to cetuximab or other EGFR antibody
* Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
* Symptomatic brain metastasis
* Has a diagnosis of immunodeficiency or is …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.