A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)

Conditions
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Pancreatic Cancer, Advanced Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreatic Neoplasms

Intervention / Treatment
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* Drug: anti-EGFR-bispecific antibody armed activated T-cells


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pancreatic Adenocarcinoma<br>Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment. | Drug: anti-EGFR-bispecific antibody armed activated T-cells<br>* Phase I: First 3 participants, twice weekly infusions of 10^10 EGFR BATs infusions If there is toxicity in 0 or 1 of 3 participants, 3 additional participants will be added to the dose level of up to 10^10. If >/= 2 of 6 participants experience DLTs, then the dose will be reduced to 7.5 x 10^9 per infusion If only 0 or 1 participants has toxicity in the first 6, then the study will proceed to enroll in the expansion cohort Expansion cohort: - 8 infusions of 7.5 x 10^9 or 10^10 EGFR BATs in 22 evaluable participants (including the 6 participants treated at the maximum tolerated dose in Phase I)<br>* Other names: EGFR BATs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate toxicity | The NCI CTEP CTCAE v4.0 will be used. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFR-BAT, bispecific antibody-armed activated T cells, Pancreatic cancer, memorial sloan kettering cancer center, 18-463