NCT02662348

T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System

Status unknown Phase 1 Last updated 20 January 2016

What this trial tests

Phase 1 trial testing Recombinant Human Interleukin-2 in Esophageal Cancer in 6 participants. Status unknown.

Timeline

1 February 2016

Primary endpoint
1 November 2017

1 November 2017

Quick facts

Lead sponsor	Yi Miao
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	1 February 2016
Primary completion	1 November 2017
Estimated completion	1 November 2017
Sites	1 location across China

Drugs / interventions tested

• Recombinant Human Interleukin-2 — full drug profile →
• HER2Bi-Armed T Cells — full drug profile →

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →
• Gastric Cancer — all drugs for Gastric Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Liver Cancer — all drugs for Liver Cancer →

Sponsor

Yi Miao — full company profile →

Who can join

Adults 18 to 65, any sex, with Esophageal Cancer or Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety as measured by local and systemic toxicities
  Time frame: Up to 1 year

Sponsor's own description

This phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.

Publications & conference data

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

1. Understanding Esophageal Cancer: The Challenges and Opportunities for the Next Decade.
   Yang J, Liu X, Cao S, Dong X, et al · · 2020 · cited 134× · PMID 33014854 · DOI 10.3389/fonc.2020.01727
2. Overview of current targeted therapy in gallbladder cancer.
   Song X, Hu Y, Li Y, Shao R, et al · · 2020 · cited 123× · PMID 33028805 · DOI 10.1038/s41392-020-00324-2
3. Overcoming Challenges for CD3-Bispecific Antibody Therapy in Solid Tumors.
   Middelburg J, Kemper K, Engelberts P, Labrijn AF, et al · · 2021 · cited 122× · PMID 33466732 · DOI 10.3390/cancers13020287
4. Bi-specific and tri-specific antibodies- the next big thing in solid tumor therapeutics.
   Runcie K, Budman DR, John V, Seetharamu N. · · 2018 · cited 120× · PMID 30249178 · DOI 10.1186/s10020-018-0051-4
5. Recent advances of bispecific antibodies in solid tumors.
   Yu S, Li A, Liu Q, Yuan X, et al · · 2017 · cited 114× · PMID 28931402 · DOI 10.1186/s13045-017-0522-z
6. Development and clinical application of anti-HER2 monoclonal and bispecific antibodies for cancer treatment.
   Yu S, Liu Q, Han X, Qin S, et al · · 2017 · cited 82× · PMID 29209558 · DOI 10.1186/s40164-017-0091-4
7. Biliary tract cancers: current knowledge, clinical candidates and future challenges.
   Tariq NU, McNamara MG, Valle JW. · · 2019 · cited 79× · PMID 31015767 · DOI 10.2147/cmar.s157092
8. Clinical Pharmacology and Translational Aspects of Bispecific Antibodies.
   Trivedi A, Stienen S, Zhu M, Li H, et al · · 2017 · cited 53× · PMID 28297195 · DOI 10.1111/cts.12459