Actively Recruiting
Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)
Led by Baylor College of Medicine · Updated on 2025-11-13
38
Participants Needed
1
Research Sites
871 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
Texas Children's Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a gene transfer study for patients with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL) that has come back or has not gone away after treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. For example, T lymphocytes can kill cancer cells but there normally are not enough of them to kill all the cancer cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study targets CD19, CD20 and CD22. This antibody sticks to ALL cells because of a substance on the outside of these cells called CD19, CD20 and/or CD22. For this study, the antibody to CD19, CD20 and CD22 has been changed so that instead of floating free in the blood, it is now joined to the T cells. When T-cells contain an antibody that is joined to them, they are called chimeric antigen receptor- T cells or CAR-T cells. In the laboratory, we have also found that T cells work better if we also add proteins that stimulate them. One such protein is called 4-1BB. Adding the 4-1BB molecule makes the cells grow better and last longer in the body, giving them a better chance of killing the leukemia cells. In this study we are going to attach the CD19/CD20/CD22 chimeric receptor that has 4-1BB added to the patient's T cells. We will then test how long the cells last. These T cells, called "TRICAR-ALL" T cells are investigational products not approved by the Food and Drug Administration (FDA) outside the context of a clinical trial.
CONDITIONS
Official Title
Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and/or CD22
- Age between 1 and 25 years
- Life expectancy of at least 8 weeks
- Weight of 10 kg or more
- Ability to provide informed consent or assent according to age and local regulations
- Discontinuation of all anti-cancer agents with specified washout periods prior to cell collection
- Adequate organ function and performance status
- Agreement to use effective contraception if of childbearing/fathering potential
- Willingness to participate in long term follow-up for up to 15 years
- Availability of transduced T-cells with at least 15% expression of CD19, CD20, or CD22 CAR by flow cytometry
- Specific criteria related to disease status, including marrow relapse or refractory disease with defined blast percentages
- Prohibited medications discontinued with specified washout periods before CAR-T cell infusion
You will not qualify if you...
- Active malignancy other than the disease under study
- Active severe infection, including recent positive blood culture or known viral infections such as HIV, hepatitis B, hepatitis C, or HTLV
- Primary immunodeficiency syndrome
- Pregnant or breastfeeding
- Any condition preventing study treatment as judged by investigator
- Active graft-versus-host disease or recent immunosuppressive therapy for GVHD
- Acute symptomatic central nervous system pathology requiring medical intervention
- History of isolated seizure episode within 4 weeks with underlying epileptic disorder excluded
- Ongoing corticosteroid use above specified dose for GVHD management
- Receiving immunosuppressive therapy for GVHD within 4 weeks prior to T-cell infusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Bahey Salem, MD
CONTACT
N
Nabil Ahmed, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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