RecruitingPhase 1NCT02917083

CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)

Phase I Study of Relapsed CD30 Expressing Lymphoma Treated With CD30 CAR T Cells (RELY-30)


Sponsor

Baylor College of Medicine

Enrollment

60 participants

Start Date

May 8, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

The subject has a type of lymph gland cancer called Lymphoma. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers; they both have shown promise, but have not been strong enough to cure most patients. Investigators hope that both will work better together. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to test whether these genetically modified T cells given after chemotherapy will be more effective at killing cancer cells. The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody 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. These CD30 chimeric receptor-activated T cells (CD30.CAR T cells) seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are unknown. Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions, and that this may not happen if there are too many other T cells in circulation. Because of that, doctors may use chemotherapy drugs to decrease the level of circulating T cells prior to the CD30.CAR T cells infusion. This is called "lymphodepletion" CD30.CAR T cells have previously been studied in lymphoma patients.


Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a treatment called CAR T-cell therapy — where a patient's own immune cells are genetically engineered to target and kill cancer cells — for people with Hodgkin lymphoma or non-Hodgkin lymphoma that has come back or stopped responding to previous treatments. **You may be eligible if...** - You have been diagnosed with relapsed or refractory Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) - Your cancer cells test positive for a protein called CD30 (a lab test can confirm this) - You are in good enough health to undergo the treatment (Karnofsky/Lansky score above 60%) - Your hemoglobin (red blood cell count) is at an acceptable level **You may NOT be eligible if...** - Your cancer cells do not have the CD30 protein - You are in very poor health - You have active and uncontrolled infections CAR T-cell therapy is an exciting area of cancer research that uses the body's own immune system, supercharged in the lab, to fight cancer. 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

GENETICCAR T Cells

Three dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three to six patients will be enrolled at each dose level. Each patient will receive one infusion of CAR modified T cells according to the following dosing schedule: Dose Level One: 2x10\^7 cells/m2. Dose Level Two: 1x10\^8 cells/m2. Dose Level Three: 2x10\^8 cells/m2.


Locations(2)

Houston Methodist Hospital

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

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NCT02917083


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