A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
NCT ID: NCT04137536
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
7 participants
INTERVENTIONAL
2019-10-17
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pancreatic Adenocarcinoma
Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kenneth Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Virginia (Specimen Analysis)
Charlottesville, Virginia, United States
Countries
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References
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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.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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18-463
Identifier Type: -
Identifier Source: org_study_id
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