Clinical Trial

Disease: T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, (NCT06514794)

Disease info:

T-cell acute lymphoblastic leukaemia (T-ALL) is a type of acute leukaemia meaning that it is aggressive and progresses quickly. It affects the lymphoid-cell-producing stem cells, in paticular a type of white blood cell called T lymphocytes as opposed to acute lymphoblastic leukaemia (ALL) which commonly affects B lymphocytes. A lymphoid stem cell becomes a lymphoblast cell and then one of three types of lymphocytes (white blood cells):

  • B lymphocytes that make antibodies to help fight infection.
  • T lymphocytes that help B lymphocytes make the antibodies that help fight infection.
  • Natural killer cells that attack cancer cells and viruses.

There are no specific signs or symptoms which would allow a diagnosis of T-ALL to be made. The most common signs and symptoms are caused by the bone marrow being unable to produce enough normal blood cells. T-ALL often causes swolen lymph nodes in the middle part of the chest (mediastinum) which may affect breathing or the circulation. The results of a simple blood count will usually indicate leukaemia although, rarely, a blood count may be normal. Virtually all patients with T-ALL will have bone marrow samples taken to confirm the diagnosis and to help to determine exactly what type of leukaemia a patient has. 

The main ways in which leukaemia is treated are:

  • Chemotherapy – Cell-killing drugs. Steroids are normally used along with chemotherapy for T-ALL
  • Radiation therapy – Usually only given as part of a stem cell transplant in T-ALL
  • Stem cell transplant – Younger/fitter patients may be given a stem cell transplant (bone marrow transplant). This is done using healthy stem cells from a donor. This is also done for T-ALL if chemotherapy does not cure the disease. 

Lymphoblastic lymphoma is an aggressive form of non-Hodgkin lymphoma that accounts for approximately 2% of all non-Hodgkin lymphomas. It usually develops from T-lymphocytes but can occasionally develop from B-lymphocytes.

People with this condition typically experience painless swelling in the neck, armpit, or groin caused by enlarged lymph nodes. In 50-75% of cases, a central chest mass develops which may cause difficulty breathing and chest pain. Other symptoms include fatigue, loss of appetite, weight loss, night sweats, and unexplained fevers.

Lymphoblastic lymphoma primarily affects younger individuals, being most common in people under 35 years of age, with peak diagnosis at 20 years. It is slightly more common in men than women. Whilst the exact causes are unknown, risk factors include exposure to radiation or pesticides and immunosuppression.

Treatment involves intensive chemotherapy divided into induction, consolidation, and maintenance phases, with additional treatments such as radiotherapy and stem cell transplantation used in selected cases.

Source (for lymphoblastic lymphoma): Leukaemia Foundation

Frequency:
An estimated 6,100 people will be diagnosed with ALL in the United States in 2025. Lymphoblastic lymphoma is relatively rare, accounting for approx. 2% of all non-Hodgkin lymphomas, is very rare in adults but much more prevalent in children and teens.
Official title:
A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)
Who:

Study Director: Cherry Thomas, MD,Wugen, Inc.

Sponsor:
Partners:
Locations:

United States, California Duarte, California, United States, 91010 Recruiting City of Hope

United States, California Los Angeles, California, United States, 90027 Recruiting Children's Hospital Los Angeles

United States, Missouri Saint Louis, Missouri, United States, 63108 Recruiting Washington University Saint Louis

United States, Pennsylvania Philadelphia, Pennsylvania, United States, 19390 Recruiting Children's Hospital of Philadelphia

United States, Texas Houston, Texas, United States, 77030 Recruiting MD Anderson Cancer Center

Australia, Victoria Melbourne, Victoria, Australia, 3000 Recruiting Peter Mac Callum Cancer Institute

Australia, Victoria Melbourne, Victoria, Australia, 3000 Recruiting Royal Children's Melbourne

Study start:
Jan. 31, 2025
Enrollment:
125
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
CD7 & TRAC
Delivery method:
Electroporation - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active not recruiting

Description

This is a Phase 2, single-agent study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.

The study is divided into 2 disease Cohorts. The Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease, defined as ≥5% blast in the BM and/or extramedullary disease (EMD) only. An exploratory MRD positive cohort will evaluate patients in complete remission with MRD positive disease (>0.1 but < 5% blasts in the BM)

Data for each age group will be reviewed by the Data Safety Committee (DSC) following enrollment of 12 patients.

Last updated: Jun. 23, 2025
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