Clinical Trial

Disease: Relapsed or Refractory Multiple Myeloma, MM, (NCT05308875)

Disease info:

Multiple myeloma is a cancer that develops in the bone marrow, the spongy tissue found in the centre of most bones. Multiple myeloma is characterised by abnormalities in plasma cells, a type of white blood cell. In myeloma, these abnormal cells multiply uncontrollably, increasing from about one percent of cells in the bone marrow to the majority of bone marrow cells. The abnormal cells form tumours within the bone, causing bone pain and an increased risk of fractures.

Relapsed myeloma refers to when a patient had active treatment that their disease responded to, went off treatment and then the disease came back. 

Refractory myeloma is a disease that is progressing despite active treatment.

 

Frequency:
Multiple myeloma occurs in approximately 4 per 100,000 people per year; there are currently about 100,000 affected individuals in the United States.
Official title:
Clinical Study of the Safety and Efficacy of Non-viral Site-directed Integrated PD1-BCMA-CART in Adult Treatment of Relapsed or Refractory Multiple Myeloma
Who:

Contact

Name: Wei Li, PhD

Phone:  +8618621670308

Email: adamweili@126.com

Partners:

The First Affiliated Hospital of Zhengzhou University

Locations:

China, Henan

First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan, China, 450052

Study start:
Dec. 1, 2022
Enrollment:
9 participants
Gene editing method:
Undisclosed
Type of edit:
Knock-out
Gene:
PDCD1 (encodes PD-1)
Delivery method:
Undisclosed - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

Using gene editing, chimeric antigen receptors recognising B cell maturation antigen BCMA were integrated into subject self-derived T cells to obtain a large number of BCMA-CART by in vitro amplification, and BCMA-CART back into the subjects could identify and kill myeloma cells in the subjects. This open-label, dose-escalation study was designed to evaluate the safety and anti-tumour efficacy of PD1-BCMA-CART in the treatment of relapsed or refractory multiple myeloma.

Last updated: Apr. 20, 2024
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