RecruitingPhase 1NCT03690011

Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells

Cell Therapy for High Risk T-cell Malignancies Using CD7-Specific CAR Expressed on Non-Edited T Cells (CRIMSON-NE)


Sponsor

Baylor College of Medicine

Enrollment

27 participants

Start Date

Aug 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Max Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of cell therapy where a patient's own immune T cells are genetically engineered to recognize and destroy cancer cells carrying a protein called CD7, which is found on certain types of T-cell leukemia and lymphoma (blood cancers that affect T immune cells). **You may be eligible if...** - You have a relapsed or refractory (returned or treatment-resistant) T-cell leukemia or lymphoma, such as T-ALL, T-NHL, or other T-cell cancers - Your cancer tests positive for the CD7 protein (found on at least 20% of cancer cells) - You are eligible for a bone marrow transplant and a suitable donor has been identified - You are willing to proceed to transplant if the cell therapy works - You are generally in acceptable health - Life expectancy is more than 12 weeks **You may NOT be eligible if...** - You are not a candidate for bone marrow transplant - You do not have a suitable donor identified - Your cancer does not carry the CD7 protein - Your blood counts or organ function do not meet minimum requirements - You are over 75 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICCD7.CAR/28zeta CAR T cells

Three dose levels will be evaluated: * Dose level one: 1×10\^7 cells/m\^2 * Dose level two: 3×10\^7 cells/m\^2 * Dose level three: 5x10\^7 cells/m\^2 * Dose level four: 1×10\^8 cells/m\^2


Locations(2)

Houston Methodist Hospital

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03690011


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