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CAR T-cell Therapy

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

Phase 1

Waitlist Available

Led By Leslie Popplewell

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

City of Hope (COH) pathology review confirms that research participant's diagnostic material is consistent with history of intermediate or high grade B-cell NHL (e.g., DLBCL, MCL, or transformed NHL)

Research participants enrolled are patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high grade B-cell non-Hodgkin lymphoma (NHL) (e.g. diffuse large B-cell lymphoma [DLBCL], mantle cell lymphoma [MCL], or transformed NHL), and that have either (1) recurrence/progression following prior therapy, or (2) verification of high-risk disease in first or subsequent remission

Must not have

Active autoimmune disease requiring systemic immunosuppressive therapy

Any standard contraindications to myeloablative HSCT per standard of care practices at COH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the highest possible dose of memory-enriched T cells that can be given to patients with B-cell NHL that has returned after previous treatment. T cells are 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 to make them more effective at recognizing and killing lymphoma cells. The goal of this trial is to see if this treatment can lower the chances of the cancer recurring.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to immune response as the body adjusts to modified T cells, such as fever or fatigue; there could also be risks associated with genetic modification like unintended changes in other cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

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

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

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have brain metastases from my cancer.

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

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

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I rely on corticosteroids for my health condition.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events attributable to the cellular immunotherapy product

Incidence of dose limiting toxicities (DLTs), defined as any grade 3 or higher toxicity, any grade 3 or greater autoimmune toxicity, or failure for a research participant with documented T cell persistence to engraft by day 21 post HSCT

MTD of autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing TN/MEM-enriched T cells based on DLTs

+1 more

Secondary study objectives

Engraftment of the transferred T cell product

Levels of CD19+ B-cell precursors in the bone marrow, used as a surrogate for the in vivo effector function of transferred CD19-specific T-cells