Comparison of Autogenic and Allogenic NK Immunotherapy on the Outcome of Recurrent Solid Tumors

Fuda Cancer Hospital, Guangzhou

Status and phase: Completed; Phase 2

Conditions: Malignant Solid Tumour

Treatments: Biological: NK immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02853903

Auto-allo NK

Details and patient eligibility

About

The aim of this study is the efficacy of autogenic and allogenic natural killer (NK) immunotherapy on recurrent solid tumors.

Full description

By enrolling patients with multiple kinds of solid tumor adapted to enrolled criteria, this study will document for the first time the short/long term efficacy of auto/allogenic NK cells.The outcome will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Enrollment: 20 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
• Body tumor 1-6, the maximum tumor length < 5 cm
• KPS ≥ 70, lifespan > 6 months
• Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion criteria

• Patients with cardiac pacemaker
• Patients with brain metastasis
• Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Allogenic NK immunotherapy

Experimental group

Description:

In this group, the patients will receive more than 4 times of allogenic NK immunotherapies in 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Treatment:

Biological: NK immunotherapy

Autogenic NK immunotherapy

Active Comparator group

Description:

In this group, the patients will receive more than 4 times of autogenic NK immunotherapies in 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Treatment:

Biological: NK immunotherapy