Clinical Trial

Disease: T-Cell Acute Lymphoblastic Leukaemia (T-ALL), and Lymphoma, T-LL, (NCT05885464)

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 particular 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.

The most common signs and symptoms of T-ALL are caused by the bone marrow being unable to produce enough normal blood cells. T-ALL often causes swollen 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 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 therap: Usually only given in conjunction with 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. 

Lymphoma is a type of blood cancer that develops when white blood cells called lymphocytes grow out of control. Lymphocytes are part of our immune system. They travel around our body in our lymphatic system, helping us fight infections. There are two types of lymphocyte: T lymphocytes (T cells) and B lymphocytes (B cells).

Lymphomas can be grouped as Hodgkin lymphomas or non-Hodgkin lymphomas, depending on the types of cell they contain. T-cell lymphomas are non-Hodgkin lymphomas that develop from T lymphocytes.

Most T-cell lymphomas develop from mature T cells. They usually affect older adults, typically people in their mid-60s. They are more common in men than in women. Occasionally, T-cell lymphoma can develop from immature T cells. This is known as T-cell lymphoblastic lymphoma. It tends to affect children and young adults.

In most cases, it is not known what causes T-cell lymphomas. In a few types of T-cell lymphoma, research has shown that certain viral infections or medical conditions can increase the risk of developing lymphoma. 

Human T-lymphotropic virus type 1 (HTLV-1) is linked with development of adult T-cell leukaemia/lymphoma (ATL).
Past infection with Epstein-Barr virus (EBV) is linked to the development of a range of lymphomas, including angioimmunoblastic T-cell lymphoma (AITL).
Enteropathy-associated T-cell lymphoma (EATL) is linked with coeliac disease.

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.


The American Cancer Society’s estimates approximately 6,540 new cases of Acute Lymphoblastic Leukaemia (ALL) in 2023, accounting for less than 1% of all cancers in the United States.
Official title:
A Phase 1/2, Dose-Exploration and Dose-Expansion Study Evaluating the Safety and Efficacy of Multiplex Base-Edited, Allogeneic Anti-CD7 CAR-T Cells (BEAM-201) in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LL)


Medical Information

Phone: 857-327-8641



United States, California
Stanford University School of Medicine, Stanford, California, United States, 94304

United States, Colorado
Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

United States, Kansas 
The University of Kansas Cancer Center, Fairway, Kansas, United States, 66205

United States, Ohio 
Cleveland Clinic- Taussig Cancer Center, Cleveland, Ohio, United States, 44106

United States, Pennsylvania 
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

United States, Tennessee 
Sarah Cannon- TriStar Bone Marrow Transplant, Nashville, Tennessee, United States, 37203

United States, Texas 
Methodist Hospital - Texas Transplant Institute, San Antonio, Texas, United States, 78229

Study start:
May. 25, 2023
102 participants
Gene editing method:
Base editing
Type of edit:
Multiplex gene knock-out and knock-in
T Cell Receptor Alpha Constant (TRAC) CD7 PDCD1 CD52
Delivery method:
Electroporation - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to < 12 years), and a Phase 2 cohort.

Last updated: Jan. 28, 2024
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