Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 1/2
Started
2019-01-01
Last updated
2024-06-26
Condition(s) studied
Anti-cancer Cell ImmunotherapyT Cell and NK Cell
Investigational drug(s) / intervention(s)
ITNK cell therapy
ITNK cell therapy: Infusion of ITNK/CAR-ITNK cells
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The safety and tolerance of the ITNK cell immunotherapy — 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.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
More Second Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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