Clinical Trials /

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

NCT04137536

Description:

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer
  • Official Title: Phase Ib Treatment of Advanced Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Bispecific Antibody Armed Activated T-Cells (BATs)

Clinical Trial IDs

  • ORG STUDY ID: 18-463
  • NCT ID: NCT04137536

Conditions

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

Interventions

DrugSynonymsArms
anti-EGFR-bispecific antibody armed activated T-cellsEGFR BATsPancreatic Adenocarcinoma

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Pancreatic AdenocarcinomaExperimentalParticipants 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

Eligibility Criteria

        Inclusion Criteria:

          -  Histological or cytological proof of pancreatic adenocarcinoma. Must have metastatic
             pancreatic cancer who have received at least first line chemotherapy. Disease
             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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Evaluate toxicity
Time Frame:1 year
Safety Issue:
Description:The NCI CTEP CTCAE v4.0 will be used.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • EGFR-BAT
  • bispecific antibody-armed activated T cells
  • Pancreatic cancer
  • memorial sloan kettering cancer center
  • 18-463

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