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CAR T-cell Therapy

CAR-T Cells for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By C. Babis Andreadis, MD

Research Sponsored by C. Babis Andreadis

Eligibility Criteria Checklist

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

Must have

PET-positive disease according to 'Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification'

Patients must have a diagnosis of relapsed or refractory B-cell NHL including DLBCL, Mantle Cell, Follicular Lymphoma, Lymphoplasmacytic lymphoma, Small Lymphocytic Lymphoma, Primary Mediastinal B-Cell Lymphoma, Burkitt Lymphoma, transformed lymphoma

Must not have

HIV seropositivity

Autologous transplant within 6 weeks of planned CAR-T cell infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Summary

This trial will test if it's safe to give patients their own genetically modified T cells, which have been changed to target the B cell surface antigen CD19.

Who is the study for?

Adults with certain types of B-cell Non-Hodgkin Lymphoma that have relapsed or didn't respond to previous treatments can join. They should not be eligible for stem cell transplant, must have tried at least two systemic therapies, and still show CD19 positive cells. Key organ functions need to be within normal ranges, they shouldn't have other active cancers or severe illnesses, and women who can get pregnant must agree to use contraception for a year after treatment.

What is being tested?

The trial is testing genetically modified T cells that target CD19 on the surface of B cells. Patients will receive Cyclophosphamide and Fludarabine as part of the preparation before getting these anti-CD19 CAR-T cells infused into their bloodstream.

What are the potential side effects?

Possible side effects include immune system reactions leading to symptoms like fever and fatigue (cytokine release syndrome), nerve damage symptoms (neurotoxicity), allergic reactions during infusion, low blood cell counts increasing infection risk, and potential harm to organs such as liver or kidneys.

Eligibility Criteria

Inclusion Criteria

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

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My lymphoma shows up on PET scans.

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I have a type of B-cell NHL that has come back or didn't respond to treatment.

Exclusion Criteria

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

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I am HIV positive.

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I had a stem cell transplant using my own cells less than 6 weeks ago.

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I have an autoimmune disease and need medication to suppress my immune system.

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My body weight is less than 40 kilograms.

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I have no active cancer except for non-dangerous skin cancer or very early stage cancers.

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I have a significant brain or spinal cord condition.

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I do not have an active hepatitis B or C infection.

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I do not have any unmanaged ongoing illnesses.

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I have previously received CAR-T cell therapy targeting CD19.

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

Proportion of participants who experience a dose-limiting toxicity (DLT)

Proportion of participants with treatment-emergent adverse events (AEs)

Secondary study objectives

Complete Response rates over time

Duration of response

Overall Response rates over time

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment RegimenExperimental Treatment3 Interventions

Apheresis (1 day): Autologous lymphocytes/ mononuclear cell collection will be collected through standard apheresis procedures as per University of California, San Francisco (UCSF) institutional practices CAR-T cell manufacturing (estimated \~13-14 days) Lymphodepleting chemotherapy: 3 days of immunosuppressive chemotherapy. Cyclophosphamide given at a dose of 300 mg/m2/IV and fludarabine given at 30 mg/m2 /IV on days -5, -4, and -3. CAR-T cell infusion (1 day): The infusion of CAR-T cells targeting CD19 will occur over 5-30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2320

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisOTHER

928 Previous Clinical Trials

4,720,982 Total Patients Enrolled

C. Babis AndreadisLead Sponsor

4 Previous Clinical Trials

118 Total Patients Enrolled

C. Babis Andreadis, MD5.05 ReviewsPrincipal Investigator - University of California, San Francisco

University of California, San Francisco

3 Previous Clinical Trials

105 Total Patients Enrolled

5Patient Review

I have never experienced such amazing care and compassion from a medical team. The staff at UCSF truly understand and care about their patients.

Media Library

anti-CD19 CAR-T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04545762 — Phase 1

Non-Hodgkin's Lymphoma Research Study Groups: Treatment Regimen

Non-Hodgkin's Lymphoma Clinical Trial 2023: anti-CD19 CAR-T cells Highlights & Side Effects. Trial Name: NCT04545762 — Phase 1

anti-CD19 CAR-T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04545762 — Phase 1

~1 spots leftby Oct 2024

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