Phase I Study of Relapsed CD30 Expressing Lymphoma Treated With CD30 CAR T Cells (RELY-30)
Baylor College of Medicine
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.
Description
To prepare the CD30.CAR T cells, research staff will take some blood from the subject. This would be drawn as two separate blood collections. Alternatively, if the subject's blood counts are low, staff may collect the cells needed to prepare T cells by a pheresis procedure. This procedure will involve placing a needle in both arms, collecting the cells over 3 to 6 hours during which the subject will be required to lie relatively still. After the T cells have been collected, some of them will be activated stimulating them with antibodies and will then be infected with a retroviral vector (a s…
Eligibility
- Age range
- 12–75 years
- Sex
- All
- Healthy volunteers
- No
PROCUREMENT Inclusion Criteria: 1. Diagnosis of relapsed/refractory HL or NHL. 2. CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time) 3. Hgb ≥ 7.0 (may be a transfused value) 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. 5. Karnofsky or Lansky score of \> 60% TREATMENT Inclusion Criteria: 1. Diagnosis of relapsed/refractory HL or NHL. 2. CD30-positive tumor as assayed in a CLIA certified pathology laboratory. 3. Age 16 to 75 for the first three patients…
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 HospitalHouston, Texas
- Texas Children's HospitalHouston, Texas