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CAR T-cell Therapy

anti-CD19 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My lymphoma shows up on PET scans.

Select...

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

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

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

Primary outcome measures

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

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

Secondary outcome measures

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

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisOTHER

911 Previous Clinical Trials

4,709,483 Total Patients Enrolled

C. Babis AndreadisLead Sponsor

3 Previous Clinical Trials

86 Total Patients Enrolled

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

University of California, San Francisco

2 Previous Clinical Trials

73 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

Frequently Asked Questions

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

What key goals is this medical study aiming to achieve?

"This clinical trial will last approximately 15 months, with the principal objective of determining a proportion of participants who experience dose-limiting toxicity. Secondary objectives include measuring progression-free survival (PFS) and duration of response in responders, as well as partial response rates over the course of the study."

Answered by AI

Is it possible to participate in this trial at the moment?

"Affirmative. Clinicaltrials.gov lists this medical trial as actively recruiting and provides evidence that it was first posted on September 11th, 2020 with an amendment made to the protocol on May 2nd 2022. The study is searching for 36 individuals from a single location."

Answered by AI

To what extent is the participant pool growing for this research?

"Accurate. The information published on clinicaltrials.gov suggests that this medical trial is currently seeking volunteers. It was initially posted on the 11th of September 2020, and its most recent update occurred on May 2nd 2022. 36 participants must be recruited from 1 research centre for this study to be completed."

Answered by AI

What other empirical examinations have been carried out involving anti-CD19 CAR-T cells?

"Currently, there are 889 clinical trials running for anti-CD19 CAR-T cell therapy. Of these studies, 161 have progressed to phase 3. The majority of these trails take place in Philadelphia, Pennyslvania but they span across 28443 different sites around the world."

Answered by AI

What medical conditions have been shown to benefit from anti-CD19 CAR-T cell therapy?

"The anti-CD19 CAR-T cell therapy is most frequently utilized as a treatment for multiple sclerosis, however it has been proven successful in treating mixed-cell type lymphoma, leukemia, myelocytic and acute retinoblastoma."

Answered by AI

What has been concluded in regards to the regulatory status of anti-CD19 CAR-T cells?

"A score of 1 was attributed to the anti-CD19 CAR-T cell therapy due to it being a Phase 1 trial, which implies there is limited evidence for its effectiveness and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

C. Babis Andreadis 2020. "Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04545762.

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