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CAR T-cell Therapy

CAR T-Cell Therapy for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Led By Mazyar Shadman

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

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

Must have

Patients must meet specific eligibility criteria for lymphodepletion chemotherapy

Patients must be capable of understanding and providing a written informed consent

Must not have

Patients with concurrent known additional malignancy that is progressing and/or requires active treatment

Patients with active autoimmune disease requiring systemic immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for people with cancer that has come back or didn't respond to other treatments. They are testing how safe and effective it is.

Who is the study for?

Adults with certain types of B cell non-Hodgkin lymphoma or chronic lymphocytic leukemia that have relapsed or are refractory. They must understand the study, be willing to use contraception, and meet health criteria including organ function and performance status. Excluded are those with recent significant heart disease, active autoimmune diseases needing steroids, HIV positive individuals, pregnant or breastfeeding women, and those with other progressing cancers.

What is being tested?

The trial is testing genetically modified T-cells targeting CD20 in patients with specific B cell malignancies. It aims to determine the optimal dose for safety and effectiveness. The process includes leukapheresis (to collect white blood cells), followed by laboratory biomarker analysis, chemotherapy conditioning (with Cyclophosphamide and Fludarabine Phosphate), then infusion of engineered T-cells.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever and fatigue; complications from low blood counts like infections; possible damage to organs targeted by the modified T-cells; infusion-related reactions; and general discomfort from chemotherapy drugs.

Eligibility Criteria

Inclusion Criteria

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

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I meet the requirements for a specific type of chemotherapy to reduce my white blood cells.

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I can understand and sign the consent form.

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I have B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia.

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My DLBCL has not responded to treatment or has come back.

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I can care for myself but may need occasional help.

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My lymphoma affects my brain or spinal cord.

Exclusion Criteria

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

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I have another cancer that is getting worse or needs treatment.

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

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I am taking 15 mg or more of prednisone daily.

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I am not pregnant or breastfeeding.

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I have a history of significant brain disorders not related to lymphoma.

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I have had serious heart problems in the last 6 months.

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I have received treatments targeting CD19 or CD20, or been part of a clinical trial.

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I have low B cell counts due to previous treatments.

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I do not have CNS issues, GVHD, or any uncontrolled infections.

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

Dose-limiting toxicity

Secondary study objectives

Complete remission

Incidence of adverse events

Overall survival (OS)

+1 more

Awards & Highlights

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 (CD20-specific CAR T cell, chemotherapy)Experimental Treatment5 Interventions

Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Leukapheresis

2016

Completed Phase 2

~710