CD30 CAR T-Cells for Lymphoma
(CARCD30 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byHelen E Heslop, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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. Antibodies are proteins the protect the body from diseases caused by germs or toxic substances. They work by binding those germs or substances, which stops them from growing and causing bad effects. 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 been shown promise, but have not been strong enough to cure most patients. This study combines the two methods. We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. We now want to see if we can attach a new gene to T cells that will help them do a better job at recognizing and killing lymphoma cells. The new gene we will put in T cells makes an antibody called anti-CD30. The antibody alone has 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 chimeric receptor-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. We have found that T cells that are also trained to recognize the EBV virus (that causes infectious mononucleosis) can stay in the blood stream for many years. These are called EBV specific Cytotoxic T Lymphocytes. By joining the anti-CD30 antibody to the EBV CTLs, we believe that we will also be able to make a cell that can last a long time in the body and recognize and kill lymphoma cells. We call the final cells CD30 chimeric receptor EBV CTLs. T We hope that these new cells may be able to work longer and target and kill lymphoma cells. However, we do not know that yet.

Research Team

Helen E Heslop, MD

Principal Investigator

Baylor College of Medicine/Center for Cell and Gene Therapy

Eligibility Criteria

This trial is for children and adults with relapsed CD30+ Hodgkin's or Non-Hodgkin's Lymphoma, or those who can't complete standard therapy. Participants must be EBV positive, not pregnant, willing to use effective birth control, have a certain level of blood oxygenation and organ function, and sign informed consent.

Inclusion Criteria

AST 3 times or less than upper limit of normal.

Hgb > 8.0

Bilirubin 1.5 times or less than upper limit of normal.

See 19 more

Exclusion Criteria

Pregnant or lactating.

I do not have an active infection with HIV, HTLV, HBV, or HCV.

I have received rituximab within the last 4 months or my CD19+ B cells are at least 2%.

See 7 more

Treatment Details

Interventions

autologous CAR.CD30 EBV specific-CTLs (CAR T-cell Therapy)

Trial OverviewThe study tests genetically modified T cells that target lymphoma by combining an anti-CD30 antibody with EBV-specific T cells. This aims to create long-lasting 'chimeric receptor' T cells capable of recognizing and killing lymphoma more effectively than previous treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: autologous CAR.CD30 EBV specific-CTLsExperimental Treatment1 Intervention

Group One Dose (CTLs CAR.CD30) at Day 0: 2x10\^7 cells/m2 Group Two Dose (CTLs CAR.CD30) at Day 0: 5x10\^7 cells/m2 Group Three Dose (CTLs CAR.CD30) at Day 0: 1x10\^8 cells/m2