Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer

GC Cell

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Biological: Activated T lymphocyte

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965718

ILC-IIT-01

Details and patient eligibility

About

Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer

Full description

This was designed as a single-center, single group clinical trial, and subjects include patients with pathologically-confirmed Gemcitabine refractory advanced pancreatic cancer.

If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression and the quality of life should be investigated.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject who signed the written consent form by themselves, protectors or legal representatives prior to the clinical trial after the person in charge explained fully about objectives, procedure and the characteristics of the study drug.
2. Patient aged 18 to 75
3. Patient with pathologically-confirmed, advanced pancreatic cancer
4. ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score)
5. Patient with anticipated survival period of more than 3 months
6. Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy
7. Patient whose blood test, renal function test and liver function test results meet the following conditions.

Exclusion criteria

1. Patient with the medical history of immunodeficiency or autoimmune disease that could be aggravated by immunotherapy (examples: rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, adolescent Insulin-Dependent Diabetes Mellitus, etc.)
2. Confirmed immunodeficient patient
3. Patient with the history of cancer other than skin cancer, local prostate cancer or carcinoma in situ of cervix within the last 5 years of the start of study
4. Patient who has received systemic anti-angiogenic agent
5. Patient who has received a chemotherapy other than Gemcitabine based chemotherapy
6. Obvious myocardial failure or uncontrolled arterial hypertension
7. Patient who has experienced serious allergy (judged by the investigator)
8. Patient with serious psychological disease (judged by the investigator)
9. Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period
10. Patient who has participated in another clinical trial within the last 4 weeks of the start of study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Immuncell-LC group

Experimental group

Description:

Intravenous dripping of 200 ml (109\~2 1010 lymphocytes/60 kg adult) for 1 hour.

Treatment:

Biological: Activated T lymphocyte