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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT02917083
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CAR T Cells — GENETIC
    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.

Study Details

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.

Key Dates

Start date
May 8, 2017
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Feb 29, 2040

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD30.CAR T Cells
    Each patient will receive one infusion of CAR modified T cells. Unless post autologous transplant, patients will receive lymphodepleting chemotherapy as three daily doses of cyclophosphamide (Cy: 500mg/m2/day) together with fludarabine (Flu:30mg/m2/day) from 48 hours to 2 weeks before T cell infusion. Clofarabine (20 mg/m2/day) may be substituted for fludarabine.

Primary Outcome Measure

Number of Patients with Dose-Limiting Toxicities (DLT) [ Time Frame: 6 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Carlos A Ramos, MD
[email protected]
832-824-4817
Vicky Torrano, RN
[email protected]
832-824-7821
Texas Children's HospitalHoustonTexas77030
Carlos A Ramos, MD
[email protected]
832-824-4817
Vicky Torrano, RN
[email protected]
832-824-7821

Find similar trials in Houston, TX

By research site
Houston Methodist Hospital· Houston, TXTexas Children's Hospital· Houston, TX

Related Studies