Wearable tech, AI and clinical teams combine to change the face of clinical trial monitoring
23 January 2023
Publish date: 10 June 2021
Researchers at the NIHR UCLH Clinical Research Facility are the first in the world to start a new first-in-human trial investigating a novel treatment, called NVG-111, in patients with Non-Hodgkin lymphoma (NHL) subtypes, including relapsed/refractory chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL) and mantle cell lymphoma (MCL).
This multi-centre trial, sponsored and funded by NovalGen Limited (a UCL spinout company), will also take place at additional centres. At UCLH the trial will be led by Dr William Townsend, a consultant haematologist who leads a comprehensive portfolio of early phase trials in lymphoproliferative disorders.
Development of this novel drug was led by UCL Professor Amit Nathwani who is also founder of NovalGen, Chief Executive Officer and member of the Board of Directors. Professor Nathwani has a track record in research in haematological disorders and has an international reputation for his work in cancer research, immunology and gene therapy.
NHL usually originates in lymphoid tissues (cells and organs important in the immune response, including bone marrow, thymus, and lymph nodes) and the incidence increases with age. Options for chemotherapy-resistant patients currently remain limited, and new therapies are needed.
NVG-111, a first-in-class bispecific antibody T-cell engager which is designed to be effective in the killing of cancer cells without affecting healthy immune cells.,. In preclinical studies, NVG-111 showed efficacy in a range of hard-to-treat blood cancers as well as solid tumours.
The trial will be conducted in two parts: in Part A, sequential doses will be tested to identify Dose Limiting Toxicities (DLTs) and used to decide dose to be studied in Part B. Part B will include one cohort of patients with CLL/SLL and one with MCL to further assess the efficacy and safety profile of NVG-111.
The maximum duration of participation for each patient is up to 32 months. This includes up to a four week screening period, a treatment period of up to six cycles, and a safety follow-up conducted four weeks after the last dose as well as up to 24 months long term follow-up.
Dr. Townsend, Consultant Hematologist at UCLH and Principal Investigator at NIHR UCLH Clinical Research Facility said: “I am very excited to be helping to bring this novel therapy to the CRF for the benefit of our patients. It is particularly gratifying as this drug was developed through the UCL laboratories and helps to deliver on the UCL/UCLH bench-to-bedside research vision.
“The dosing of our first patient marks a significant milestone for NovalGen. NVG-111, is our first clinical program for patients with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma,” said Professor Nathwani. “We are developing bispecific therapies that can safely harness the immune system to treat both haematologic malignancies and solid tumors and have an exciting pipeline of products in development.”
The NIHR UCLH Clinical Research Facility has continued to set up and implement clinical trials throughout the Covid-19 pandemic in compliance with the UCLH Research Directorate Covid-19 and Research Policy to progress the development of new treatments for serious and life-threatening diseases.
Image: Anusorn / Adobe Stock
23 January 2023
10 January 2023