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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04137536
• Other study ID #: 18-463
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 17, 2019
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• anti-EGFR-bispecific antibody armed activated T-cells
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)

Locations

Country	Name	City	State
United States	University of Virginia (Specimen Analysis)	Charlottesville	Virginia
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate toxicity	The NCI CTEP CTCAE v4.0 will be used.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center