NCT03634501

Clinical Study on Anti-tumor Effect Induced by Activated Primary Natural Killer（NK）Cells

Status unknown Phase 1, PHASE2 Last updated 11 January 2019

What this trial tests

Phase 1, PHASE2 trial testing Activated NK in Lung Cancer in 200 participants. Status unknown.

Timeline

26 October 2018

Primary endpoint
30 September 2021

30 September 2022

Quick facts

Lead sponsor	Xuanwu Hospital, Beijing
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	26 October 2018
Primary completion	30 September 2021
Estimated completion	30 September 2022
Sites	1 location across China

Drugs / interventions tested

• Activated NK — full drug profile →

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →
• Breast Cancer — all drugs for Breast Cancer →
• Colon Cancer — all drugs for Colon Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Xuanwu Hospital, Beijing

Who can join

Adults 18 to 75, any sex, with Lung Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will analyze and evaluate the following items:

1. The safety of natural killer（NK） cells for treatment of subjects with solid tumors. Forty patients will be enrolled for each of the five cancers (in total 200 patients will be enrolled).
2. The effectiveness of natural killer（NK）cell therapy alone or with chemotherapy or targeted drugs.

Subjects from 18 to 75 years of age who are diagnosed with a solid tumor including pancreatic cancer, lung cancer, breast cancer, ovarian cancer and colon cancer, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures:

Peripheral blood will be collected from a vein of arm. Peripheral blood mononuclear cells（PBMC） will be isolated and purified for NK manufacturing. After 14\~21 days cultivation, activated NK will be harvested and formulated for clinical administration.

Subjects will receive NK cell treatment by intravenous infusion. The frequency is once every 3 or 4 weeks for the first 3 months. Participants who respond well after 3 months may be eligible to continue NK cell therapy; and those not may receive NK therapy combined with chemotherapy and/or targeted drugs, or chemotherapy/targeted drugs alone.

Evaluations during therapy including:

1. Clinical assessment, and history of medications;
2. Blood draws for routine and research tests, including but not limited to: lymphocyte population and circulating tumor cell analysis in peripheral blood;
3. CT scan, bone scan and positron emission tomography（PET ）scan, if indicated, for disease evaluation;
4. Pharmacokinetics study after NK infusion. For this test, the number of NK cells in the blood is measured over time at indicated time-points.

Publications & conference data

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

1. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
2. NK cells and solid tumors: therapeutic potential and persisting obstacles.
   Tong L, Jiménez-Cortegana C, Tay AHM, Wickström S, et al · · 2022 · cited 134× · PMID 36319998 · DOI 10.1186/s12943-022-01672-z
3. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
4. Pancreatic Cancer and Immunotherapy: A Clinical Overview.
   Timmer FEF, Geboers B, Nieuwenhuizen S, Dijkstra M, et al · · 2021 · cited 92× · PMID 34439292 · DOI 10.3390/cancers13164138
5. The role of natural killer cell in gastrointestinal cancer: killer or helper.
   Wang F, Lau JKC, Yu J. · · 2021 · cited 66× · PMID 33262461 · DOI 10.1038/s41388-020-01561-z
6. 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
7. Naturally Killing the Silent Killer: NK Cell-Based Immunotherapy for Ovarian Cancer.
   Nersesian S, Glazebrook H, Toulany J, Grantham SR, et al · · 2019 · cited 55× · PMID 31456796 · DOI 10.3389/fimmu.2019.01782
8. The Immune Landscape of Breast Cancer: Strategies for Overcoming Immunotherapy Resistance.
   Retecki K, Seweryn M, Graczyk-Jarzynka A, Bajor M. · · 2021 · cited 34× · PMID 34885122 · DOI 10.3390/cancers13236012