OncoMatch/Clinical Trials/NCT03690011
Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells
Is NCT03690011 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for t-cell acute lymphoblastic lymphoma.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD7 positive (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry) (≥20% CD7 positive blasts)
CD7-positive tumor (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory)
Disease stage
Required: Stage REFRACTORY
Prior therapy
Cannot have received: investigational agent
Currently receiving any investigational agents or having received any tumor vaccines within the previous 6 weeks
Cannot have received: tumor vaccine
having received any tumor vaccines within the previous 6 weeks
Lab requirements
Blood counts
Hgb ≥ 7.0 (can be transfused); PT and APTT <1.5 × upper limit normal (if pheresis required)
Kidney function
Estimated GFR ≥ 50 mL/min; Cr < 1.5 upper limit normal (if pheresis required)
Liver function
AST < 5 × upper limit normal; Bilirubin < 3 × upper limit normal
Cardiac function
Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF≤30% or LVEF≤50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment). Pulse oximetry of > 90% on room air
AST < 5 × upper limit normal; Bilirubin < 3 × upper limit normal; Estimated GFR ≥ 50 mL/min; Cr < 1.5 upper limit normal (if pheresis required); Hgb ≥ 7.0 (can be transfused); PT and APTT <1.5 × upper limit normal (if pheresis required); Pulse oximetry of > 90% on room air; Cardiac criteria as listed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Houston Methodist Hospital · Houston, Texas
- Texas Children's Hospital · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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