NCT04650724

Clinical Study of T Cell Infusion Targeting BCMA Chimeric Antigen Receptor

Single Arm, Single Center, Open Label Clinical Trial of BCMA Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With BCMA Positive Recurrent or Refractory Multiple Myeloma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells. BCMA is a specific surface protein of B lymphocytes, which plays an important role in the development, proliferation and differentiation of B cells. BCMA is highly expressed in malignant mm plasma cells and provides a large number of anti apoptotic signals, which makes bcam an ideal target in targeted immunotherapy. At present, a variety of immunotherapy strategies targeting BCMA are being carried out in laboratory and clinical practice, which have achieved encouraging therapeutic effects in multiple myeloma and effectively promoted the development of targeted immunotherapy.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	T cell infusion agent targeting BCMA chimeric antigen receptor	Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.

Timeline

• Start date: 2018-10-11
• Primary completion: 2018-12-20
• Completion: 2020-10-01
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

1 site across 1 country: China