CAR T-Cell Treatment for Lymphoma
(CASEY Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byBilal Omer, 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

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This study is for patients that have lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease and the patients condition has come back or has not gone away after treatment, including the best treatment we know for these diseases. Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV). This virus causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma. This suggests that the EBV plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in blood and affect the tumor. We have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses (meaning the cancer could no longer be detected). We think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study we will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. We know that T cells need substances called cytokines (substances such as proteins released by specific cells of the immune system) to survive and that the cells may not get enough cytokines after the cells are infused into the body. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on the cancer.

Eligibility Criteria

This trial is for patients with certain lymph gland diseases, including Hodgkin or non-Hodgkin Lymphoma, T/NK-lymphoproliferative disease, who have not responded well to existing treatments. It's particularly aimed at those whose cancer cells show signs of the Epstein Barr virus (EBV), which is linked to these conditions.

Inclusion Criteria

My cancer has returned after a period of remission.

I am 75 years old or younger.

My tumor is CD70 positive with at least 30% CD70+ cells.

+5 more

Exclusion Criteria

I have been diagnosed with acute promyelocytic leukemia.

I do not have an active second cancer or was treated for another cancer within the last 2 years.

I do not have an active HIV or HTLV infection.

+2 more

Participant Groups

The study tests a new gene therapy using modified T cells that target EBV-infected tumor cells. These T cells are engineered with a C7R gene to help them survive longer and potentially improve their ability to fight the cancer. The goal is to determine the safest high dose and its effectiveness against the cancer.

1Treatment groups

Experimental Treatment

Group I: Treatment Arm AExperimental Treatment1 Intervention

Patients will initially be consented for procurement of blood for generation of the transduced T-cells. Three dose levels will be evaluated and a possible dose level -1 in case of unexpected toxicity at dose level 1. Each patient will receive one T cell infusion.

C7R-EBV T cells is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as EBV-specific T cells for: