Induced-T Cell Like NK Cellular Immunotherapy for Cancers That Are Lack of MHC-I Expression
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The safety and tolerance of the ITNK cell immunotherapy
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with advanced cancer, which express low or no MHC-I.
- •Life expectancy >12 weeks
- •Adequate heart,lung,liver,kidney function
- •Available autologous T cells
- •Informed consent explained to, understood by and signed by patient/guardian.
- •Patient/guardian given copy of informed consent.
Exclusion Criteria
- •Had accepted gene therapy before;
- •Severe virus infection such as HBV,HCV,HIV,et al
- •Known HIV positivity
- •History of liver or other organ transplantation
- •Active infectious disease related to bacteria, virus,fungi,et al
- •Other severe diseases that the investigators consider not appropriate;
- •Pregnant or lactating women
- •Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
- •Other conditions that the investigators consider not appropriate.
Outcomes
Primary Outcomes
The safety and tolerance of the ITNK cell immunotherapy
Time Frame: 2 years
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.
Secondary Outcomes
- Percent of Patients with best response as either complete remission or partial remission.(2 years)