Memory-Enriched T Cells for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByLeslie Popplewell

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I trial studies the highest possible dose of memory enriched T cells that can be given following standard stem cell transplant before unmanageable side effects are seen in patients with B-cell non-Hodgkin lymphoma that has returned after previous treatment. A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Memory enriched T cells will be made from a patient's own T cells that are genetically modified in a laboratory. This means that the T cells are changed by inserting additional pieces of deoxyribonucleic acid (genetic material) into the cell to make it recognize and kill lymphoma cells. Memory enriched T cells may kill the cells that are not killed by stem cell transplant and may lower the chances of the cancer recurring.

Eligibility Criteria

This trial is for patients with recurrent B-cell non-Hodgkin lymphoma who are eligible for a stem cell transplant. They must have a life expectancy of at least 16 weeks, not require oxygen support, and have good organ function. Pregnant women or those on corticosteroids/immunosuppressives can't join. Participants need to agree to use contraception during the study.

Inclusion Criteria

My B-cell NHL diagnosis is confirmed to be intermediate or high grade.

I have a type of aggressive B-cell lymphoma and need a stem cell transplant due to recurrence or high-risk disease.

I had a stem cell transplant without disease progression after my last treatment.

I do not need medication to maintain my blood pressure and do not have heart rhythm problems.

I have a stored frozen T cell product ready for use.

I am eligible for a stem cell transplant using my own cells.

I don't need extra oxygen and my oxygen level is 90% or higher without assistance.

My kidney function is normal, with creatinine below 1.6 mg/dL.

I am mostly able to care for myself and carry out normal activities.

I do not have any ongoing infections that are not under control.

Exclusion Criteria

I am on medication to suppress my immune system due to an autoimmune disease.

I don't have any health issues that would prevent me from undergoing a stem cell transplant.

I have brain metastases from my cancer.

I am not currently on any experimental treatments or undergoing chemotherapy or radiation.

I understand the study's details and the risks and benefits of participating.

I rely on corticosteroids for my health condition.

I have had a stem cell transplant from a donor or myself.

Participant Groups

The trial tests genetically modified T cells made from the patient's own immune cells after a stem cell transplant. These 'memory enriched' T cells are designed to recognize and kill lymphoma cells that survived the transplant, potentially preventing cancer recurrence.

2Treatment groups

Experimental Treatment

Group I: Arm 2 (autologous TN/MEM-enriched T cells)Experimental Treatment2 Interventions

Patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing TN/MEM-enriched T cells IV over 10 minutes on day 2 or 3 following HSCT.

Group II: Arm 1 (autologous TCM-enriched T cells)Experimental Treatment2 Interventions

Patients receive autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing TCM-enriched T cells IV over 10 minutes on day 2 or 3 following HSCT.