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 (Jun 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
Demographics
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 →Frequently asked questions
Is NCT03690011 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent, tumor vaccine disqualifies patients from enrollment.
Does this trial require CD7?
Yes, CD7 positive (≥20% CD7 positive blasts by flow cytometry or immunohistochemistry) is a required biomarker for enrollment.
What disease stage is eligible?
Stage REFRACTORY is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify