Induced-T Cell Like NK Cellular Immunotherapy for Cancer Lack of MHC-I
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ITNK cell therapy.
- Who it may be relevant to
- Registry conditions: Anti-cancer Cell Immunotherapy, T Cell and NK Cell. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Induced-T Cell Like NK Cellular Immunotherapy for Cancers That Are Lack of MHC-I Expression
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.
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.
Interventions
- Biological ITNK cell therapy
Infusion of ITNK/CAR-ITNK cells
Primary outcome measures
- The safety and tolerance of the ITNK cell immunotherapy [Time frame: 2 years]
Secondary outcome measures (1)
- Percent of Patients with best response as either complete remission or partial remission. [Time frame: 2 years]
Eligibility criteria
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. 6. 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
Publications
- Li P, Burke S, Wang J, Chen X, Ortiz M, Lee SC, Lu D, Campos L, Goulding D, Ng BL, Dougan G, Huntly B, Gottgens B, Jenkins NA, Copeland NG, Colucci F, Liu P. Reprogramming of T cells to natural killer-like cells upon Bcl11b deletion. Science. 2010 Jul 2;329(5987):85-9. doi: 10.1126/science.1188063. Epub 2010 Jun 10. PMID 20538915
- Jiang Z, Qin L, Tang Y, Liao R, Shi J, He B, Li S, Zheng D, Cui Y, Wu Q, Long Y, Yao Y, Wei Z, Hong Q, Wu Y, Mai Y, Gou S, Li X, Weinkove R, Norton S, Luo W, Feng W, Zhou H, Liu Q, Chen J, Lai L, Chen X, Pei D, Graf T, Liu X, Li Y, Liu P, Zhang Z, Li P. Human induced-T-to-natural killer cells have potent anti-tumour activities. Biomark Res. 2022 Mar 24;10(1):13. doi: 10.1186/s40364-022-00358-4. PMID 35331335
Identifiers
NCT: NCT03882840 · ZZITNK-007