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"Phase II/Pilot Study of 2nd Generation Anti-CEA Esigner T Cells in Adenocarcinomas"

Phase 2
18 Years
80 Years
Open (Enrolling)
Metastatic Cancers

Thank you

Trial Information

"Phase II/Pilot Study of 2nd Generation Anti-CEA Esigner T Cells in Adenocarcinomas"

CEA is perhaps the most prominent tumor marker among malignancies of epithelial origin:
colorectal carcinoma, with 60-94% of tumors positive in patients with advanced disease;
breast carcinoma, with 30-60% of metastatic cases positive for CEA; and cancers of the lung,
liver, pancreas, head and neck, bladder, cervix and prostate with 30% or more with CEA+

The application of these therapies in the four Phase II/Pilot clinical sub studies listed
below proceed after collecting patient lymphocytes by leukapheresis, which are then modified
by transfer of the chimeric gene for Ig-CD28-TCRzeta. Cells are selected in culture with
amplification and activation of the now-specific anti-tumor T cells. These are then re
infused into the patients, with IL2 supplementation, and toxicity and response are

There are four sub studies embedded within this Phase II Study of Second Generation Designer
T Cells in CEA-expressing Adenocarcinomas. The embedded studies are:

- A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Gastric
Cancers (CEA-G)

- A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Colorectal
Cancers (CEA-C)

- A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Lung Cancers

- A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Solid Tumors

A total of 12 subjects per protocol or a total of 48 subjects will be enrolled combining the
enrollment of the 4 CEA-expressing protocols.

Inclusion Criteria:

- Inclusion Criteria

- Patients with histologically confirmed diagnosis of CEA-expressing adenocarcinoma.
Patient may have measurable tumor by physical examination or by radiologic studies,
and/or evaluable disease, including bone lesions. Soluble CEA is not acceptable as
the sole measure of disease, although it may be followed in addition to measurable or
other evaluable disease.

- Tumor must be CEA-expressing as demonstrated by elevated serum CEA levels(>10 ng/ml).
Preference will be given to patients with CEA >100 ng/mL to increase the sensitivity
of CEA as a measure of the tumor response.

Where preserved tumor tissue is available, direct immuno¬histochemical staining of tumor
is obtained to demonstrate CEA expression on tumor cells.

- Patient must be at least 18 years of age.

- Patient able to understand and sign informed consent.

- Patient with a life expectancy of greater than four months.

- Patient failed standard potentially curative therapy.

- Patient with performance status of 0 to 1 (ECOG).

- Patient with adequate organ function as defined by:

- ANC 1.0, platelets 50,000, Hgb 8.0; patient may be transfused to achieve Hgb 8.0
to satisfy enrollment criteria, or as otherwise indicated by symptoms for Hgb

- Creatinine 1.5mg/dl or creatinine clearance 60cc/min.

- Direct bilirubin 1.5 mg/dl.

- No evidence of congestive heart failure, symptoms of coronary artery disease,
serious cardiac arrhythmias, including atrial fibrillation/atrial flutter,
evidence of prior myocardial infarction by history or by EKG.

A normal cardiac stress test for inducible ischemia or arrhythmia within 12 weeks prior
to enrollment for all patients over 50 years old or those with abnormal EKG or any history
or symptoms suggestive of cardiac disease.

-- No serious, symptomatic obstructive or emphysematous lung disease, or asthma requiring
intravenous medications within the past 12 months; no serious lung disease associated with
dyspnea at normal activity levels grade III) or at rest (grade IV), due to any cause
(including cancer metastases and pleural effusions). The patient will be ineligible if
PFTs show an FEV1 <1.3 liters or a DLCO <50% within 12 weeks of study entry.

Exclusion Criteria:

- Female patients of childbearing age will be tested for pregnancy; pregnant patients
will be excluded from the study. Males who are actively seeking to have children will
be made aware of the unknown risks of this study protocol of human sperm and the need
to practice birth control.

- Patients with serious or unstable renal, hepatic, pulmonary, cardio¬vascular,
endocrine, rheumatologic, or allergic disease based on history, physical exam and
laboratory tests will be excluded, as outlined in section 5.2.8.

- Patients with active clinical disease caused by CMV, hepatitis B or C, HIV or
tuberculosis will be excluded from the study.

- Patients who have had cytotoxic and/or radiation therapy in the four weeks prior to
entry into the trial will be excluded.

- Patients with other concurrent malignancies will be excluded.

- Patients requiring systemic steroids will be excluded.

- Patients previously treated with investigational agents will be excluded

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

Monitoring of CEA levels, pre and post infusion of T cells. Monitoring of CT and PET scans pre and post infusion.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Richard P Junghans, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roger Williams Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

August 2015

Related Keywords:

  • Metastatic Cancers
  • T cells
  • gene transfer
  • immunotherapy
  • metastatic cancers
  • lung cancer
  • gastric cancer
  • colorectal cancer
  • solid tumors
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Roger Williams Medical CenterProvidence, Rhode Island  02908-4735