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Chemotherapy

Cell Therapy for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Led By Elizabeth L 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

History of relapse after achieving first remission with primary therapy, or failure to achieve remission with primary therapy

Karnofsky performance scale (KPS) >= 70%

Must not have

Dependence on corticosteroids

Research participant(s) with known active hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new treatment for lymphoma that uses genetically engineered cells to try to kill the cancer.

Who is the study for?

This trial is for adults with high-risk B-cell non-Hodgkin lymphoma who've had a relapse or didn't respond to initial treatment. They must be fit enough for stem cell transplant (Karnofsky score ≥70%), not pregnant, and have a life expectancy over 16 weeks. Excluded are those with HIV, prior transplants, active autoimmune diseases needing steroids, hepatitis B/C infection, or on other trials.

What is being tested?

The study tests genetically engineered lymphocyte therapy after stem cell transplant in patients with aggressive lymphoma. It includes rituximab and chemotherapy before the transplant and factors like filgrastim to help move stem cells from bone marrow into the blood for collection.

What are the potential side effects?

Possible side effects include immune system reactions due to engineered lymphocytes, infusion-related symptoms from rituximab, bone marrow suppression by chemotherapy, and complications related to stem cell transplantation such as infections.

Eligibility Criteria

Inclusion Criteria

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

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My cancer returned after initial treatment or didn't respond to the first treatment.

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I am able to care for myself but may not be able to do active work.

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

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My biopsy was reviewed and confirmed to be a type of intermediate grade B-cell NHL.

Exclusion Criteria

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

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I rely on corticosteroids for my health condition.

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I have an active hepatitis B or C infection.

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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 had a stem cell transplant from a donor or myself.

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I am scheduled for a treatment that combines radiation therapy and immunotherapy.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Days of Quantifiable CD19 CAR Post T-cell Infusion

Number of Participants With Dose Limiting Toxicities (DLTs)

Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background

Secondary study objectives

Failure to Engraft

Progression-free Survival at 1 Year

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cellular adoptive immunotherapy following PBSCT)Experimental Treatment7 Interventions

Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with G-CSF and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

FDA approved

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~2090

Filgrastim

FDA approved