Status:
ACTIVE_NOT_RECRUITING
A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
University of Virginia
Conditions:
Pancreatic Cancer
Advanced Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 al...
Eligibility Criteria
Inclusion
- 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
- 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 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
- 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
- A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy.
- 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
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04137536
Start Date
October 17 2019
End Date
April 1 2026
Last Update
May 15 2025
Active Locations (2)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
University of Virginia (Specimen Analysis)
Charlottesville, Virginia, United States, 22908