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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04137536
Collaborator
University of Virginia (Other)
7
2
1
41.5
3.5
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Study Details

Study Description

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
  • Drug: anti-EGFR-bispecific antibody armed activated T-cells
Phase 1

Study Design

Study Type:
Interventional
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 :
Oct 17, 2019
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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 Names:
  • EGFR BATs
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluate toxicity [1 year]

      The NCI CTEP CTCAE v4.0 will be used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    2 University of Virginia (Specimen Analysis) Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • University of Virginia

    Investigators

    • Principal Investigator: Kenneth Yu, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04137536
    Other Study ID Numbers:
    • 18-463
    First Posted:
    Oct 24, 2019
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021