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

The word tumor does not always imply cancer. In discussing tumors that are malignant (cancerous), however, the term solid tumor is used to distinguish between a localized mass of tissue and leukemia.

Between 2006 and 2016, the global leukaemia incidence increased to 466,802 cases. Non-Hodgkin lymphoma increased by 45%, from 319,078 to 461,164 cases. More than 1.9 million new cancer cases are expected to be diagnosed in the US in 2023.
Official title:
A Long-term Follow-up Study of Subjects With Malignancies Treated With CRISPR CAR T Cellular Therapies

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
70 participants
Gene editing method:
Type of edit:
Gene enhancements
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


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. 5, 2024
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