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

Phase 2RecruitingNCT03882840

Second Affiliated Hospital of Guangzhou Medical University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anti-cancer Cell Immunotherapy T Cell and NK Cell

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The safety and tolerance of the ITNK cell immunotherapy

A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ITNK cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. Incidence of treatment-emergent adverse events will be calculated as standard methods.

Time frame: 2 years

Secondary Outcomes

Percent of Patients with best response as either complete remission or partial remission.

Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.