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CAR T-cell Therapy

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

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Dose-limiting toxicity

Secondary outcome measures

Complete remission

Incidence of adverse events

Overall survival (OS)

+1 more

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

1995

Completed Phase 3

~3770

Leukapheresis

2016

Completed Phase 2

~690

Fludarabine Phosphate

1997

Completed Phase 3

~2390

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,322 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,345 Total Patients Enrolled

Mustang BioIndustry Sponsor

3 Previous Clinical Trials

621 Total Patients Enrolled

Media Library

Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03277729 — Phase 1 & 2

Marginal Zone Lymphoma Research Study Groups: Treatment (CD20-specific CAR T cell, chemotherapy)

Marginal Zone Lymphoma Clinical Trial 2023: Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor Highlights & Side Effects. Trial Name: NCT03277729 — Phase 1 & 2

Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03277729 — Phase 1 & 2

Frequently Asked Questions

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

What is the current enrollment count for this experiment?

"Affirmative. According to clinicaltrials.gov, this study is currently recruiting eligible individuals and was first posted on December 5th 2017 with its last update being July 11th 2022. The trial hopes to enroll 35 participants at a single site."

Answered by AI

Is enrollment for this experiment open at present?

"According to information hosted on clinicaltrials.gov, this research project is actively seeking participants and has been since it was first posted in December 2017 with the most recent update occuring in July of 2022."

Answered by AI

What maladies are most widely treated using Chimeric Antigen Receptor T-Cell Therapy?

"Chimeric Antigen Receptor T-Cell Therapy offers healing potential to those suffering from multiple sclerosis, mixed-cell type lymphoma, and acute myelocytic leukemia."

Answered by AI

Are there any documented precedents of Chimeric Antigen Receptor T-Cell Therapy trials?

"Currently, 889 trials concerning Chimeric Antigen Receptor T-Cell Therapy are underway with 161 of those in the late stages. Most studies originate from Philadelphia, Pennsylvania yet there are numerous other sites conducting research on this therapeutic modality around the world - 28443 locations to be exact."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas

2017. "A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03277729.

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