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CAR T-cell Therapy

CAR-T Cell Therapy for Non-Hodgkin Lymphoma

Phase 1

Waitlist Available

Led By Benjamin Tomlinson, MD

Research Sponsored by Benjamin Tomlinson

Eligibility Criteria Checklist

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

Must have

Subjects must have relapsed or refractory non-Hodgkin lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen

The patient's lymphoma must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months after getting car-t infusion

Awards & highlights

Study Summary

This trialtests a new type of cancer treatment using modified white blood cells to fight the disease. It could have side effects, but could also be beneficial.

Who is the study for?

This trial is for adults with Non-Hodgkin's Lymphoma that has returned or didn't respond after two treatments. They must have a certain level of blood cells, CD19 positive lymphoma, decent physical function, and normal organ function. People can't join if they've had recent transplants, CNS issues, other active cancers, uncontrolled illnesses, are pregnant/breastfeeding, have hepatitis B/C or HIV infection.Check my eligibility

What is being tested?

The study tests a new immunotherapy using modified T cells (CAR-T Cells) combined with chemotherapy drugs Cyclophosphamide and Fludarabine to target cancer in those whose Non-Hodgkin's Lymphoma hasn't responded to standard treatments.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking healthy cells (like fever or weakness), low blood cell counts leading to increased infection risk or bleeding problems, and potential damage to organs like the liver or kidneys.

Eligibility Criteria

Inclusion Criteria

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

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My non-Hodgkin lymphoma didn't respond well to at least two treatments.

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My lymphoma is CD19 positive.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months after getting car-t infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months after getting car-t infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after getting car-t infusion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of patients with Lymphoma response

Secondary outcome measures

Disease-free survival

Disease-specific survival

Duration of response

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cyclophosphamide + Fludarabine + Infusion of CAR-T CellsExperimental Treatment3 Interventions

Lymphodepletive regimen, consisting of Cyclophosphamide 60mg/kg IV on day -6 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of Chimeric antigen receptor T-cells (CAR-T) on day 0

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100