MAGE-A10c796T for advanced NSCLC
Research type
Research Study
Full title
A Phase I Dose Escalation, Open-Label Clinical Trial Evaluating the Safety and Efficacy of MAGE-A10c796T in Subjects with Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
216896
Contact name
Martin Forster
Contact email
Sponsor organisation
Adaptimmune LLC
Eudract number
2016-002518-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Lung cancer is the leading cause of all cancer-related deaths. In a type of lung cancer known as non-small cell lung cancer (NSCLC), treatment responses in advanced cases have reached a plateau of approximately 25% – 35%. The 2 year survival rate remains short at 10%-15%
Immunotherapy is a type of therapy which uses the patient’s immune system to fight their cancer. Central to the body's immune system is a type of blood cell, known as a T cell. T cells collected from the patient's blood can be genetically modified in a laboratory. Potentially the modification results in an enhanced ability of T cells to attack the patient's cancer cells. In this study the modified T cells are known as MAGE-A10c796T - the investigational drug. The study will assess safety and efficacy in certain patients with advanced NSCLC.Patients must be screened to check that they are of a particular blood type and also have a tumour which tests positive for a protein called MAGE-A10.
The trial will enrol up to 28 adult patients.
Summary:
1. Eligible patients undergo a procedure (taking 4-5 hours) to collect T cells from their blood.
2. The T cells are then genetically modified to produce the investigational drug, MAGE-A10c796T. This will be returned to the patient's bloodstream via an infusion.
3. Up to 3 days of chemotherapy are required to prepare the body for the infusion.
4. Following chemotherapy, the patient receives the MAGE-A10c796T.
5. Patients are monitored closely under the follow-up schedule - this reduces to 6 monthly visits after 2 years.
5. Follow-up continues until the patient leaves the study or their cancer worsens.
Thereafter, the patient will be followed-up for 15 years for ongoing safety
review.The potential role for immunotherapy and the unmet medical need provides the rationale for investigation of MAGE-A10c796T in the advanced NSCLC population.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0048
Date of REC Opinion
26 Apr 2017
REC opinion
Further Information Favourable Opinion