Clinical Trial

Disease: Hematologic and Solid Malignancies, (NCT06208878)

Disease info:

Haematological cancers most often begin in the bone marrow where blood is produced. Stem cells in the bone marrow develop into white blood cells, red blood cells, or platelets. Blood cancers occur when uncontrolled growth of abnormal blood cells overtakes the development of normal blood cells and interferes with the regular functions of these cells. Blood cancers fall into three categories: leukaemia, lymphoma, and myeloma.

Leukaemias are blood cell cancers; some leukaemias are fast growing, while others develop slowly. Lymphoma occurs when lymphocytes (infection-fighting white blood cells) develop abnormally and become cancerous. These multiply and aggregate in lymph nodes and other tissues. Among common lymphomas are Hodgkin lymphoma, non-Hodgkin Lymphoma, AIDS-related lymphoma, and primary central nervous system (CNS) lymphoma. Myeloma is a cancer that occurs in plasma cells. Normal plasma cells produce antibodies that fight disease and infection. However, when abnormal plasma cells develop, they interfere with  antibody production and lead to reduced immunity.

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Solid tumour types are named according to the type of cell they originate from. Examples of solid tumours are sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours.

The word tumour does not always imply cancer. In discussing tumours that are malignant (cancerous), however, the term solid tumour is used to distinguish between a localised mass of tissue and leukaemia.

Frequency:
Excluding non-melanoma skin cancers, over 2 million new cancer cases are expected to be diagnosed in the US in 2025.
Official title:
A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies
Who:
Partners:
Locations:

United States, Oregon 
Oregon Health and Science University, Portland, Oregon, United States, 97239

United States, Pennsylvania 
University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Study start:
Nov. 22, 2023
Enrollment:
70 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene enhancements
Gene:
Delivery method:
- Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Enrolling by invitation

Description

All subjects with hematological and solid malignancies who are enrolled in a parent study and were exposed to allogeneic CRISPR CAR T cellular therapy will be asked to participate in this long-term follow-up (LTFU) study. Subjects who have completed the parent study for the protocol-defined duration, or who have discontinued the parent study early, or who are in secondary follow-up (follow up of subjects with progressive disease or who receive a subsequent line of anticancer therapy) in the parent study may enroll in this LTFU study. This will allow for collection of long-term efficacy data (as applicable) and safety data up to 15 years post-treatment with CRISPR CAR T cellular therapies.

Last updated: Feb. 24, 2025
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