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Treatment of Advanced Colorectal or Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Armed Activated T-Cells (Phase Ib)

Phase 1
18 Years
Open (Enrolling)
Colorectal Cancer, Cancer of Pancreas, Pancreatic Neoplasm, Malignant Neoplasm of Large Intestine, Malignant Tumor of Colon, Colon Carcinoma, Cancer of Colon, Pancreatic Cancer

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Trial Information

Treatment of Advanced Colorectal or Pancreatic Cancer With Anti-CD3 x Anti-EGFR-Armed Activated T-Cells (Phase Ib)

The purpose of this study is to determine in a dose-escalation phase Ib trial the safety of
3 infusions of EGFR2Bi armed activated T cells (aATC), after chemotherapy, for patients with
advanced colorectal and pancreatic cancer

Inclusion Criteria:

- Histological or cytological proof of colorectal or pancreatic adenocarcinoma

- Must have metastatic colorectal cancer or pancreatic cancer with stable disease
after first line chemotherapy or patients with colorectal or pancreatic cancer who
have progressed with standard chemotherapy options*

- Standard chemotherapy for metastatic colorectal cancer include 5-FU/capecitabine with
either oxaliplatin or irinotecan based regimen with or without bevacizumab or

- Standard chemotherapy for metastatic pancreatic cancer include gemzar based regimen
or FOLFIRINOX (5-FU, oxaliplatin, and irinotecan)

- Prior cetuximab, panitumumab, or other monoclonal antibody therapy allowed if given
28 days prior to the 1st infusion of armed T cells

- Absolute Neutrophil Count (ANC) ≥ 1,000/mm3

- Lymphocyte count ≥ 400/mm3

- Platelet Count ≥ 50,000/mm3

- Hemoglobin ≥ 8 g/dL

- Serum Creatinine < 2.0 mg/dl, Creatinine Clearance ≥50 ml/mm (can be calculated)

- Total Bilirubin ≤ 2 mg/dl (biliary stent is allowed)

- SGPT and SGOT < 5.0 times normal

- LVEF ≥ 45% at rest (MUGA or Echo)

- Pulse Oximetry of >88%

- Age ≥ 18 years at the time of consent

- Written informed consent and HIPAA authorization for release of personal health

- 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

- KPS ≥ 70% or SWOG Performance Status 0 or 1

Exclusion Criteria:

- Any chemotherapy related toxicities from prior treatment.(> grade I 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 Protocol version: 07/13/2011 8

- Symptomatic brain metastasis

- Chronic treatment with systemic steroids or another immuno-suppressive agent

- 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

- HIV infection

- Positive HbsAg

- Positive Hepatitis C

- Active bleeding or a pathological condition that is associated with a high risk of

- Uncontrolled systemic disease like active infections

- Nonmalignant medical illnesses that are uncontrolled or a controlled illness that 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

Minor changes from these guidelines will be allowed at the discretion of the attending
team under special circumstances. The reasons for exceptions will be documented.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determining in a dose-escalation phase Ib trial the safety of 3 infusions of EGFR2Bi aATC, and a booster infusion after 3 months, for patients with advanced colorectal or pancreatic cancer.

Outcome Description:

Participants will be assessed for changes in lab values (CBC, Sodium, potassium, calcium, magnesium, chloride, bicarbonate, glucose,BUN, creatinine, total Protein, albumin, total bilirubin, ALP, AST,ALT, CEA or CA 19-9.

Outcome Time Frame:

4 wks after chemo, prior to ATC infusion #2; 1 wk later prior to ATC infusion #3; Wks 2, 4 & 9 post ATC infusion #3; Wk 8 post ATC #4 (booster)

Safety Issue:


Principal Investigator

Minsig Choi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

February 2015

Related Keywords:

  • Colorectal Cancer
  • Cancer of Pancreas
  • Pancreatic Neoplasm
  • Malignant Neoplasm of Large Intestine
  • Malignant Tumor of Colon
  • Colon Carcinoma
  • Cancer of Colon
  • Pancreatic Cancer
  • Neoplasms
  • Carcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Pancreatic Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201