NCT03882840

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

Recruiting now Phase 1, PHASE2 Last updated 26 June 2024

What this trial tests

Phase 1, PHASE2 trial testing ITNK cell therapy in Anti-cancer Cell Immunotherapy in 60 participants. Currently enrolling.

Timeline

1 January 2019

Primary endpoint
1 January 2028

1 January 2035

Quick facts

Lead sponsor	Second Affiliated Hospital of Guangzhou Medical University
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 January 2019
Primary completion	1 January 2028
Estimated completion	1 January 2035
Sites	1 location across China

Drugs / interventions tested

• ITNK cell therapy — full drug profile →

Conditions studied

• Anti-cancer Cell Immunotherapy — all drugs for Anti-cancer Cell Immunotherapy →
• T Cell and NK Cell — all drugs for T Cell and NK Cell →

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Who can join

18 and older, any sex, with Anti-cancer Cell Immunotherapy or T Cell and NK Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. NK cell-based cancer immunotherapy: from basic biology to clinical development.
   Liu S, Galat V, Galat Y, Lee YKA, et al · · 2021 · cited 504× · PMID 33407739 · DOI 10.1186/s13045-020-01014-w
2. Breakthrough of solid tumor treatment: CAR-NK immunotherapy.
   Wang W, Liu Y, He Z, Li L, et al · · 2024 · cited 113× · PMID 38245520 · DOI 10.1038/s41420-024-01815-9
3. Natural Killer Cell Therapy: A New Treatment Paradigm for Solid Tumors.
   Oh S, Lee JH, Kwack K, Choi SW. · · 2019 · cited 60× · PMID 31614472 · DOI 10.3390/cancers11101534
4. CAR-NK as a Rapidly Developed and Efficient Immunotherapeutic Strategy against Cancer.
   Włodarczyk M, Pyrzynska B. · · 2022 · cited 35× · PMID 36612114 · DOI 10.3390/cancers15010117
5. The Advantages and Challenges of Anticancer Dendritic Cell Vaccines and NK Cells in Adoptive Cell Immunotherapy.
   Abakushina EV, Popova LI, Zamyatnin AA, Werner J, et al · · 2021 · cited 29× · PMID 34835294 · DOI 10.3390/vaccines9111363
6. Human induced-T-to-natural killer cells have potent anti-tumour activities.
   Jiang Z, Qin L, Tang Y, Liao R, et al · · 2022 · cited 16× · PMID 35331335 · DOI 10.1186/s40364-022-00358-4
7. Decoding MHC loss: Molecular mechanisms and implications for immune resistance in cancer.
   Lin P, Lin Y, Chen X, Zhao X, et al · · 2025 · cited 5× · PMID 40673641 · DOI 10.1002/ctm2.70403
8. Natural killer cell membrane manipulation for augmented immune synapse and anticancer efficacy.
   Ryu M, Kim E, Kim S, Kim K. · · 2025 · cited 5× · PMID 40585037 · DOI 10.1016/j.mtbio.2025.101965