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

Phase 1

Active, not recruiting

• Conditions: Advanced Pancreatic Cancer; Pancreatic Neoplasms; Pancreatic Adenocarcinoma; Pancreatic Cancer
• Interventions: Drug: anti-EGFR-bispecific antibody armed activated T-cells

• Registration Number: NCT04137536
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-10-17
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pancreatic Adenocarcinoma	anti-EGFR-bispecific antibody armed activated T-cells	Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.

Primary Outcome Measures

Name	Time	Method
Evaluate toxicity	1 year	The NCI CTEP CTCAE v4.0 will be used.

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Virginia (Specimen Analysis); 🇺🇸 Charlottesville, Virginia, United States