BATs Treatment for Pancreatic Cancer, Phase Ib/II

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    22
  • sponsor
    University of Virginia
Updated on 19 April 2022
cancer
serum pregnancy test
neutrophil count
EGFR
metastatic pancreatic cancer
serum total bilirubin
biliary stenting

Summary

This protocol will confirm toxicities and estimate the clinical efficacy of combining anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given to patients with locally advanced or metastatic pancreatic cancer who have received at least one dose of first line chemotherapy and may have responding, stable or progressive disease. Phase Ib will confirm a safe dose of 8 infusions, given twice weekly, of EGFR-BATs in 3 to 6 subjects. The phase II portion of the trial will test the clinical efficacy of this dose in 22 patients (including those in Phase Ib).

Description

Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure at approximately 3 to 4 weeks prior to first EGFR-BATs infusion. The white blood cells, specifically T cells, are then mixed with two proteins - OKT3 and IL-2 which activates the cells to multiply. After approximately 14 days in culture, the activated T cells are coated with the OKT3 and cetuximab to produce bispecific antibody armed T cells (BATs). Cells are then frozen and stored until scheduled to be infused.

Within one to two weeks prior to infusion of the study treatment, subjects will receive one dose of chemotherapy. The choice of chemotherapy agent(s) is at the discretion of the treating physician.

At approximately 4 weeks following leukapheresis procedure, twice weekly or weekly infusions of the BATs cells will take place (twice weekly for participants enrolled before DATE and weekly for participants enrolled after DATE). A total of eight twice weekly infusions or four weekly infusions will be given over a four week period. Please note that the weekly dose for both groups of participants is the same; participants that received twice weekly dosing received half of the weekly dose at each infusion.

Follow-up appointment schedule will include clinic visits at 1 to 2 weeks, 4 to 5 weeks, 2 months, 4 months and 6 months following the last infusion of BATs cells.

Details
Condition Locally Advanced Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma
Treatment EGFR BATs after standard of care chemo
Clinical Study IdentifierNCT03269526
SponsorUniversity of Virginia
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histological or cytological proof of pancreatic adenocarcinoma. Must have locally advanced or metastatic pancreatic cancer and received at least one dose of chemotherapy (any treatment line) and may have responding, stable or progressive disease
Expected survival ≥ 3 months
ECOG Performance Status 0 or 1
Left Ventricular Ejection Fraction (LVEF) ≥ 45% at rest (MUGA 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 10 days prior to "on study" status. If a urine or serum test is positive or cannot be confirmed as negative, the other (urine or serum pregnancy test, whichever was not performed first) will be required
Demonstrate adequate hepatic, renal, and bone marrow function as defined below; all hematological, renal, and hepatic screening labs should be performed within 10 days prior to "on study" status (alpha gal testing must be within the regular screening period)
Absolute lymphocyte count ≥ 400/mm3
Absolute neutrophil count (ANC) ≥ 1,000/mm3
Platelets ≥ 75,000/mm3
Hemoglobin ≥ 8 g/dL
Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) < 2.0 mg/dl OR ≥50 ml/mm
Serum total bilirubin ≤ 2 mg/dl (biliary stent is allowed)
AST (SGOT) and ALT (SGPT) < 5.0 times normal
Alpha 1,3 Galactose IgE ("alpha gal") < 0.35 IU/ml or "negative

Exclusion Criteria

Known hypersensitivity to cetuximab or other EGFR antibody
Treatment with any investigational agent within 14 days prior to first study intervention (apheresis) for protocol therapy
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to first study intervention (apheresis). 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 "on-study" status
Active liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus. If initial Hepatitis C test shows a positive result, the patient should have a Hepatitis viral load test to confirm. If initial HIV or Hepatitis B virus testing shows a positive result, no further testing will be done
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
Has a known history of active TB (Bacillus Tuberculosis)
Has had prior chemotherapy, radiation, hormonal, monoclonal antibody (mAb) or targeted small molecule therapy, within 2 weeks prior to the first study procedure (apheresis). Subjects who have not recovered to <Grade 3 from an adverse event due to a previously administered agent are not eligible
Has received a live vaccine within 30 days of first study procedure (apheresis)
History of a recent myocardial infarction (within one year), a past myocardial infarction (more than one year ago) along with current coronary symptoms requiring medications
Has history of another malignancy within the past 5 years. Exceptions include
basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy
in situ cervical cancer
Has active autoimmune disease that has required systemic treatment in the past 2 years
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
(i.e. with use of disease modifying agents, corticosteroids or
Females must not be breastfeeding
immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
Pt may be excluded if, in the opinion of the PI and investigator team, the pt is not capable of being compliant
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency, etc.) is not considered a form of systemic treatment
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