Actively Recruiting
Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells
Led by Baylor College of Medicine · Updated on 2025-10-23
27
Participants Needed
2
Research Sites
978 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
The Methodist Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer). The body has different ways of fighting infection and disease. This study combines two different ways of fighting disease with antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, or T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat cancer; they have shown promise, but have not been strong enough to cure most patients. T cells can kill tumor cells but there normally are not enough of them to kill all the tumor 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 is called anti-CD7. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD7. CD7 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD7 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. In the laboratory, investigators have also found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells. In this study, investigators attach the CD7 chimeric receptor with CD28 added to it to T cells. Investigators will then test how long the cells last. These CD7 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.
CONDITIONS
Official Title
Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent or refractory T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma, T-non-Hodgkin lymphoma (including various subtypes) or other cutaneous T-cell lymphomas
- Suitable for allogeneic hematopoietic stem cell transplant with a suitable donor identified
- Willing to proceed to transplant if complete remission is achieved with CD7.CAR treatment
- Tumor with at least 20% CD7-positive blasts confirmed by certified laboratory
- Age 75 years or younger; first three patients must be adults (18 years or older)
- Hemoglobin level of 7.0 or higher (transfusions allowed)
- Life expectancy greater than 12 weeks
- Kidney and liver function within defined limits if blood collection is needed
- Informed consent explained, understood, and signed by patient or guardian
You will not qualify if you...
- Active infection requiring antibiotics
- Active HIV infection
- History of other cancers except certain skin or in situ cancers treated curatively at least 2 years prior
- Currently receiving other investigational agents or tumor vaccines within 6 weeks
- Known hypersensitivity to murine protein-containing products
- Pregnant or lactating
- Tumor in location where growth could block airway
- Clinically significant viral infections or uncontrolled viral reactivation
- Certain heart conditions including recent heart attack, atrial fibrillation, severe heart dysfunction, or significant pericardial effusion
- Central nervous system abnormalities such as CNS-3 disease, uncontrolled seizures, recent stroke, dementia, cerebellar disease, or autoimmune CNS diseases
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
2
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
LaQuisa Hill, MD
CONTACT
M
Martha Arredondo
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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