Low Dose IL-2 for the Treatment of Crohn's Disease

Inclusion Criteria:

1. Age 12-80 years. Maximum age limit for subjects recruited at BCH will be 30 years.

2. A diagnosis of CD made by standard clinical, radiological, endoscopic andhistological criteria. a. A subset of patients with Ileostomies or colostomies will be permitted.

3. Adult subjects with moderate-to-severe CD (CDAI score 220-450) a. a modified CDAI will be used to assess patients with ileostomies/colostomies.Number of liquid stools per day will be substituted for number of bag empties perday.

4. Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy

5. Simple Endoscopic Score for CD (SES-CD) ≥ 6 or ≥ 4 for isolated ileal disease

6. patients with ileostomies will be assessed as patients with isolated ilealdisease via SES-CD.

7. Failure to tolerate or failure to respond to at least one conventional therapy withthe intention of inducing or maintaining remission (including but not limited tooral corticosteroids, oral 5-aminosalicylates, azathioprine and/or 6-mercaptopurine,TNF alpha antagonist, anti-integrins, ustekinumab). Corticosteroid dependency (inability to taper oral corticosteroids without a recurrence of disease activity)is also included in this category.

8. Stable doses of concomitant medications, as defined in Section 5

9. A negative pregnancy test within 2 weeks prior to anticipated commencement of thestudy drug, in female subjects of child-bearing age. Men and women of reproductivepotential must agree to use an acceptable method of birth control during treatmentand for six months after completion of treatment.

10. The ability of adult participants who are able to make their own healthcaredecisions to provide informed consent or the ability of a legal guardian to provideconsent if the participant is a child (less than 18 years of age) or has mildintellectual disability and cannot consent for him or herself. In the event that alegal guardian provides consent, the study participant must be able to demonstratean understanding of the study at his or her comprehension level and must have theability to give verbal assent. If the legal guardian is court appointed, then thelegal guardian must be able to provide documentation of court appointedguardianship.

Exclusion Criteria:

1. A diagnosis of ulcerative colitis or indeterminate colitis.

2. Requirement for immediate surgical, endoscopic or radiological intervention forperforation, sepsis, or intra-abdominal or perianal abscess.

3. History of colorectal cancer or dysplasia.

4. Positive stool test for Clostridium difficile via GDH/EIA two step testing method.PCR only testing will not be accepted. If patient is GDH positive and EIA negative,enrollment will be permitted.

5. Current medically significant infection.

6. Significant laboratory abnormalities;

7. Hb < 7.0 g/dL, WBC < 2.5 x 103/mm3, Plt < 50 x 103/mm3.

8. Creatinine ≥ 2x institutional ULN.

9. Total bilirubin > 2.0 mg/dL, ALT > 2x institutional ULN. Elevated unconjugatedbilirubin related to Gilbert's syndrome is allowed.

10. Abnormal thyroid function tests.

11. Positive serology for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).

12. Positive screening test for tuberculosis (TB).

13. Treatment with any biologic medication within 4 weeks of first study drug dose (baseline) (see below section on washouts)

14. Received another IND within 5 half-lives of that agent baseline.

15. Malignancy within the last 5 years, excluding non-melanoma skin cancer.

16. Allergy to any component of the study drug.

17. Pregnant or lactating women.

18. Inability to comply with the study protocol or inability of the subject or thesubject's legal guardian to provide informed consent.

19. Prior exposure to IL-2.

20. Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA ClassIII or IV).