Clinical trial NCT04137536: A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
Official title: Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Pancreatic Cancer
Advanced Pancreatic Cancer
Pancreatic Adenocarcinoma
Pancreatic Neoplasms
Keywords: EGFR-BAT
bispecific antibody-armed activated T cells
Pancreatic cancer
memorial sloan kettering cancer center
18-463
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2019-10-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 already received first-line standard chemotherapy.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate toxicity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlottesville
country: United States
facility: University of Virginia (Specimen Analysis)
state: Virginia
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kenneth Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park JA, Santich BH, Xu H, Lum LG, Cheung NV. Potent ex vivo armed T cells using recombinant bispecific antibodies for adoptive immunotherapy with reduced cytokine release. J Immunother Cancer. 2021 May;9(5):e002222. doi: 10.1136/jitc-2020-002222.