NCT04137536Active, not recruitingPhase 1
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 21 Oct 2019
- Start date
- 17 Oct 2019
- Primary completion date
- Apr 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT04137536
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 7
- From 17 Oct 2019 to the primary completion date, Apr 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any chemotherapy related toxicities from prior treatment, \> grade 2 per CTCAE v4.0
- Treatment with any investigational agent within 14 days prior to being registered for protocol therapy
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Steroid premedication for imaging scans is allowed. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to being registered for protocol therapy
- A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy.
Other illness
- Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Known HIV infection
- Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
- Has an active infection requiring systemic therapy
Lab values
- Known hypersensitivity to cetuximab or other EGFR antibody
Other
- Symptomatic brain metastasis
- Females must not be breastfeeding
- Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia (Specimen Analysis) Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.