HLA-Genotypes and Tumor Antigen Expression
Research type
Research Study
Full title
Assessing Frequency of HLA-Genotypes and Tumor Antigen Expression in Subjects with Relapsed/Refractory, Advanced-Stage Solid Tumors that may Qualify for Novel T Cell Receptor Based Therapies
IRAS ID
299540
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
T-knife GmbH
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The proposed Research study intends to assess the overall frequency for positivity of human leukocyte antigen (HLA)-A*02:01 and DR*04:01 genotype and the tumoral expression of melanoma-associated antigen 1 (MAGE-A1) and/or New York esophageal squamous cell carcinoma-1 (NY-ESO1) in subjects with relapsed/refractory, advanced-stage solid tumors that may express MAGE-A1 or NY-ESO1 (such as melanoma, squamous non-small cell lung cancer [NSCLC], esophageal, gastric, breast [ductal, tubular, medullary], ovarian, mesothelioma, bladder, anal, sarcomas, primitive neuroectodermal [PNET], and other solid tumors).
If MAGE-A1 and/or NY-ESO1 positivity of the tumor is detected, the subject may qualify for participation in a clinical trial with a genetically modified T cell receptor and will be informed by the Investigator about the possibilities to participate in such (a) trial(s). This information will be provided to the subject independent of any T-knife GmbH-sponsored trial as various such trials are ongoing or upcoming in the participating countries and as subjects are free to choose in which trial they wish to participate, if at all.
REC name
London - Westminster Research Ethics Committee
REC reference
21/PR/1030
Date of REC Opinion
19 Oct 2021
REC opinion
Further Information Favourable Opinion