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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Advanced Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti-EGFR-bispecific antibody armed activated T-cells

Drug

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)

Other names: EGFR BATs

Primary outcomes

Evaluate toxicity

Time frame: 1 year

The NCI CTEP CTCAE v4.0 will be used.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

University of Virginia

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2027
Study completion: 2027
First posted: Oct 24, 2019
Registry last updated: May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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