NCT03554889

Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells

Status unknown Phase 1 Last updated 13 June 2018

What this trial tests

Phase 1 trial testing NK Cell adaptive transfer in Advanced Cancer in 21 participants. Status unknown.

Timeline

1 August 2018

Primary endpoint
30 March 2019

27 November 2019

Quick facts

Lead sponsor	Hangzhou Cancer Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 August 2018
Primary completion	30 March 2019
Estimated completion	27 November 2019
Sites	1 location across China

Drugs / interventions tested

• NK Cell adaptive transfer — full drug profile →
• Nimotuzumab — full drug profile →

Conditions studied

• Advanced Cancer — all drugs for Advanced Cancer →
• ADCC — all drugs for ADCC →
• NK Cell Mediated Immunity — all drugs for NK Cell Mediated Immunity →
• Nimotuzumab — all drugs for Nimotuzumab →

Sponsor

Hangzhou Cancer Hospital

Who can join

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

Sponsor's own description

NK cells can persist and expand in vivo following adoptive transfer and may have a role in the treatment of late stage malignancies. NK also express an activating Fc receptor that mediates antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines in response to antibody-coated targets. Nimotuzumab, an monoclonal antibody against EGFR (epidermal growth factor receptor), may enhance the ADCC effect of NK cell. This study will evaluate the safety of combination of nimotuzumab and NK Cell in treating advanced cancer patients. Blood samples will also be collected for research purposes.

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. Dissecting the biology of allogeneic HSCT to enhance the GvT effect whilst minimizing GvHD.
   Blazar BR, Hill GR, Murphy WJ. · · 2020 · cited 97× · PMID 32313224 · DOI 10.1038/s41571-020-0356-4
3. Establishment of an efficient ex vivo expansion strategy for human natural killer cells stimulated by defined cytokine cocktail and antibodies against natural killer cell activating receptors.
   Nakazawa T, Morimoto T, Maeoka R, Matsuda R, et al · · 2022 · cited 22× · PMID 35919498 · DOI 10.1016/j.reth.2022.07.001
4. NK Cell Adoptive Immunotherapy of Cancer: Evaluating Recognition Strategies and Overcoming Limitations.
   Sanchez CE, Dowlati EP, Geiger AE, Chaudhry K, et al · · 2021 · cited 21× · PMID 33007496 · DOI 10.1016/j.bbmt.2020.09.030
5. Emerging Approaches for Solid Tumor Treatment Using CAR-T Cell Therapy.
   Chung H, Jung H, Noh JY. · · 2021 · cited 18× · PMID 34830003 · DOI 10.3390/ijms222212126
6. Natural killer cell-based cancer immunotherapy: from basics to clinical trials.
   Shi Y, Hao D, Qian H, Tao Z. · · 2024 · cited 17× · PMID 39415291 · DOI 10.1186/s40164-024-00561-z
7. Unleashing the power of NK cells in anticancer immunotherapy.
   Vogler M, Shanmugalingam S, Särchen V, Reindl LM, et al · · 2022 · cited 16× · PMID 34374809 · DOI 10.1007/s00109-021-02120-z
8. Advancements in adoptive CAR immune cell immunotherapy synergistically combined with multimodal approaches for tumor treatment.
   Chang Y, Chang M, Bao X, Dong C. · · 2024 · cited 15× · PMID 39308543 · DOI 10.1016/j.bioactmat.2024.08.046