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Epigenetic Modifier

Tazemetostat + CAR T Therapy for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By Samuel Yamshon, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment until death, for a maximum of approximately 6 years

Awards & highlights

Study Summary

This trial is testing if combining a pill with CAR T cell therapy can improve ability to kill lymphoma cells without safety issues in DLBCL, FL, and MCL. Participants will be followed up to 5 years.

Who is the study for?

This trial is for people with certain B-cell lymphomas (DLBCL, FL, or MCL) who have tried at least two other treatments and are eligible for standard CAR T cell therapy. It's not open to those with active HIV or hepatitis infections, pregnant or breastfeeding individuals, anyone with uncontrolled infections, or patients being treated for another cancer.Check my eligibility

What is being tested?

The study tests the combination of a drug called tazemetostat in pill form followed by standard CAR T cell therapy. The goal is to see if this combo can better target and kill lymphoma cells without greatly increasing risks. Participants will take tazemetostat before and after their CAR T treatment for up to a year.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells while targeting cancer cells, infection risk due to weakened immunity from the treatment, fatigue, nausea from pills, and potential complications from long-term immune changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment until death, for a maximum of approximately 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment until death, for a maximum of approximately 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until death, for a maximum of approximately 6 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

Number of participants who experience adverse events classified per CTCAEv5

Secondary outcome measures

Mean Overall Survival (OS)

Mean Progression-Free Survival (PFS)

Number of patients who experience cytokine release syndrome (CRS) by ASTCT Consensus Grading system during therapy

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tazemetostat and CAR T-Cell TherapyExperimental Treatment1 Intervention

Tazemetostat is being administered prior to, and following, standard of care CAR T cell therapy. The use of tazemetostat in this way is investigational.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

American Society of Clinical OncologyOTHER

34 Previous Clinical Trials

148,038 Total Patients Enrolled

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,280 Total Patients Enrolled

Applebaum FoundationUNKNOWN

Media Library

Tazemetostat (Epigenetic Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT05934838 — Phase 1

Follicular Lymphoma Research Study Groups: Tazemetostat and CAR T-Cell Therapy

Follicular Lymphoma Clinical Trial 2023: Tazemetostat Highlights & Side Effects. Trial Name: NCT05934838 — Phase 1

Tazemetostat (Epigenetic Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05934838 — Phase 1

Frequently Asked Questions

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

Are there still spots available for those interested in participating in the clinical trial?

"According to the details on clinicaltrials.gov, this medical study is no longer recruiting patients as its last update was in June 28th 2023. However, there are still 1769 other trials which are actively taking partcipants at this time."

Answered by AI

What potential risks do Tazemetostat and CAR T-Cell Therapy pose to individuals?

"Due to a paucity of evidence, the safety and efficacy ratings for Tazemetostat and CAR T-Cell Therapy are both 1 on our group's scale. This is in line with expectations as this is early Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas

2023. "A Feasibility Trial of Tazemetostat Plus CAR T Cell Therapy in B-cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05934838.