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CAR T-cell Therapy

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

Phase 1
Waitlist Available
Led By Elizabeth Budde, MD, PhD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,400 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,224 Total Patients Enrolled
Elizabeth Budde, MD, PhDPrincipal InvestigatorCity of Hope Medical Center

Media Library

Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02051257 — Phase 1
Mantle Cell Lymphoma Research Study Groups: Arm 1 (autologous TCM-enriched T cells), Arm 2 (autologous TN/MEM-enriched T cells)
Mantle Cell Lymphoma Clinical Trial 2023: Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells Highlights & Side Effects. Trial Name: NCT02051257 — Phase 1
Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02051257 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially recognized Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells as an approved therapy?

"Due to the limited amount of research done on Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells, our team at Power rated its safety as a 1. This is because this study is only in Phase 1 trials and has yet to accumulate substantial data regarding efficacy or security."

Answered by AI

Are any slots available for patients to participate in this trial?

"As per the information provided on clinicaltrials.gov, this medical study is no longer recruiting patients. This trial was first posted in June 2014 and last updated in March 2022; however, there are still 2,690 other trials actively searching for participants presently."

Answered by AI
~4 spots leftby Dec 2024