T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System

• Status: Unknown status
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yi Miao
• Collaborators: Abingen Ltd, Nanjing; Nanjing Abingen Biotech Co. Ltd
• Treatments: Aldesleukin; Interleukin-2

Criteria

Inclusion Criteria:

1. Patient with Her2-positive neoplasms of digestive system: IHC 3+

2. Clinical staging: Phase III or above

3. Ages: < 65

4. Expected survival time: > 1 year

5. Quality of Life: > 60

6. The functions of important organs( heart, liver, lung, kidney and etc.)are normal

7. The volunteers with informed consent

Exclusion criteria:

1. Patient with Her2-negative neoplasms of digestive system

2. Hepatic renal dysfunction

3. Cardiopulmonary insufficiency

4. Mental disorder

5. Allergic condition

6. With other malignant tumor

7. Lactating women

8. Patients with infection or received chemotherapy in the past two weeks

9. Patient with autoimmune disease using immunosuppressive drug

10. Patient with organ transplantation with long term use of immunosupresive drug