Induced-T Cell Like NK Cellular Immunotherapy for Cancer Lack of MHC-I

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: T Cell and NK Cell; Anti-cancer Cell Immunotherapy

Treatments: Biological: ITNK cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03882840

ZZITNK-007

Details and patient eligibility

About

T effector cells and NK cells have mutual compensatory killing functions on various of cancer types. For those cancers that have no available targets for CAR-T cell generations, we established potent T cell-like NK cells (ITNK) with a specific conversion protocol for the T cells from the patient, to perform anti-cancer therapy, especially for those cancers that are lack of MHC-I molecule expression. We have finished pre-clinical investigations for the ITNK or CAR-ITNK cell therapy and scheduled to start a clinical phase I study.

Full description

One gene can be knockout of the T cells to produce a T-like NK cells which obtain killing function of both T effector cells and NK cells. We will collect appropriate patient's T cells, produce T-like NK cells (ITNK), and infuse the ITNK/CAR-ITNK cells back to the patients to treat various of cancers.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with advanced cancer, which express low or no MHC-I.
2. Life expectancy >12 weeks
3. Adequate heart,lung,liver,kidney function
4. Available autologous T cells
5. Informed consent explained to, understood by and signed by patient/guardian. 6. Patient/guardian given copy of informed consent.

Exclusion criteria

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV,HCV,HIV,et al
3. Known HIV positivity
4. History of liver or other organ transplantation
5. Active infectious disease related to bacteria, virus,fungi,et al
6. Other severe diseases that the investigators consider not appropriate;
7. Pregnant or lactating women
8. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
9. Other conditions that the investigators consider not appropriate.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

ITNK cell therapy group

Experimental group

Description:

Patient-originated and induced T-to-natural killer (ITNK) cells, will be administrated to kill tumor cells.

Treatment:

Biological: ITNK cell therapy

CAR-ITNK cell therapy group

Experimental group

Description:

Patient-originated and induced T-to-natural killer (ITNK) cells with CAR-engineered, will be administrated to kill tumor cells.

Treatment:

Biological: ITNK cell therapy