UCD19 CAR T Cells for B-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byManali Kamdar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will test whether immune cells modified to recognize B-cell non-Hodgkin lymphoma (NHL) can be successfully manufactured at the University of Colorado Anschutz and whether these cells can be administered with an acceptable safety profile. Adults who have been diagnosed with B-cell non-Hodgkin lymphoma (NHL) that has relapsed or no longer responds to chemotherapy (relapsed or refractory) may be eligible to participate in this study. The investigators will use participants own immune cells, called T cells, to kill the lymphoma. These T cells are involved in fighting infections and in some cases, can also kill cancer cells. The investigators will extract T cells from the participant's blood, modify the cells in a laboratory, and then return teh cells to the participant's body via intravenous (IV) injection. In the laboratory, the investigators will add a new gene into the T cells that allows the T cells to recognize and kill the lymphoma cells, and allows these modified cells to multiply and increase in numbers. To put the new gene into your T cells, the investigators will use a weakened virus. The virus is modified so that it cannot multiply or spread once the cells are infused.

Eligibility Criteria

Adults aged 18-80 with B-cell non-Hodgkin lymphoma that's come back or didn't respond to treatment may join. They must have no other cure options, be in fairly good health, and not planning pregnancy for a year post-treatment. Excluded are those with recent monoclonal antibody therapy, severe psychiatric issues, certain lung/infection conditions, prior gene/CAR T cell therapy, HIV/Hepatitis B/C infection.

Inclusion Criteria

There are no other treatments that can cure your condition, as decided by your main doctor.

You do not currently have Graft-versus-Host Disease (GvHD).

Provision of signed and dated Informed Consent form

+14 more

Exclusion Criteria

You have received a type of medication called monoclonal antibody therapy within the past 14 days.

The doctor thinks that cellular therapy is not a good option for you, for any reason.

Prior therapies:

+18 more

Participant Groups

The trial is testing UCD19 CAR T Cells on adults with relapsed/refractory B-NHL. Participants' own T cells will be modified in the lab to fight cancer by adding a new gene through a weakened virus and then returned to their body via IV injection.

1Treatment groups

Experimental Treatment

Group I: UCD19 CAR T CellsExperimental Treatment1 Intervention

Participants will receive lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector \[LV\] Transduced Autologous Peripheral Blood Lymphocytes