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

NCT ID: NCT03882840

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2035-01-01

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.

Conditions

Anti-cancer Cell Immunotherapy; T Cell and NK Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ITNK cell therapy group

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

Group Type: EXPERIMENTAL

ITNK cell therapy

Intervention Type: BIOLOGICAL

Infusion of ITNK/CAR-ITNK cells

CAR-ITNK cell therapy group

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

Group Type: EXPERIMENTAL

ITNK cell therapy

Intervention Type: BIOLOGICAL

Infusion of ITNK/CAR-ITNK cells

Interventions

ITNK cell therapy

Infusion of ITNK/CAR-ITNK cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenfeng Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenfeng Zhang, MD,PhD

Role: CONTACT

zhangzhf@gzhmu.edu.cn

+862034153532

Peng Li, PhD

Role: CONTACT

lipeng@invivobio.com.cn

Facility Contacts

Zhenfeng Zhang, MD,PhD

Role: primary

zhangzhf@gzhmu.edu.cn

+86-020-34153532

References

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.

Reference Type: BACKGROUND

PMID: 20538915 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35331335 (View on PubMed)

Other Identifiers

ZZITNK-007

Identifier Type: -

Identifier Source: org_study_id