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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137536
Recruitment Status : Active, not recruiting
First Posted : October 24, 2019
Last Update Posted : October 10, 2022
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Advanced Pancreatic Cancer Pancreatic Adenocarcinoma Pancreatic Neoplasms Drug: anti-EGFR-bispecific antibody armed activated T-cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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)

Other Name: EGFR BATs


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate toxicity [ Time Frame: 1 year ]
    The NCI CTEP CTCAE v4.0 will be used.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137536


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Virginia
University of Virginia (Specimen Analysis)
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Virginia
Investigators
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Principal Investigator: Kenneth Yu, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04137536    
Other Study ID Numbers: 18-463
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
EGFR-BAT
bispecific antibody-armed activated T cells
Pancreatic cancer
memorial sloan kettering cancer center
18-463
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
 Pancreatic Diseases
Endocrine System Diseases
Antibodies
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs