Clinical Trial

Disease: Multiple Myeloma, MM, (NCT03492268)

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 characterized by abnormalities in plasma cells, a type of white blood cell. These abnormal cells multiply out of control, 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.

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:
Safety and Efficacy Evaluation of Autologous BCMA-CART for Treating Relapsed or Refractory Multiple Myeloma
Who:

Principal Investigator:Yunxiao Xu, MD  Second Xiangya Hospital of Central South University

Sponsor:

Bioray Laboratories - Bangyao Biotechnology Co., Ltd. 

Partners:

The First Affiliated Hospital of Zhengzhou University

Second Xiangya Hospital of Central South University

Locations:

China, Shanghai

Study start:
May. 10, 2021
Enrollment:
20 participants
Gene editing method:
CRISPR-Cas9
Gene:
B-Cell Maturation Antigen (BCMA)
Delivery method:
Non-viral - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT03492268
Other links:

LinkMultiple Myeloma Disease Information and FrequencyLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem Qasim

IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Suspended

Description

The trial aims to evaluate the safety and anti-tumor efficacy of autologous BCMA-CART in treating relapsed or treatment refractory multiple myeloma. BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma. Using a genetic engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in autologous T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. Patients undergo leukapheresis to separate their lymphocytes, from which CART cells are produced. Patients will receive a conditioning therapy with cyclophosphamide and fludarabine before CART therapy. BCMA-CART cells will be injected intravenously (IV) into patients on day 0.

Last updated: Jul. 24, 2022
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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