RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a clinical trial to evaluate the feasibility and safety of giving tazemetostat followed by standard of care CAR T cell infusion in previously treated diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). The investigators hypothesis is that this combination has the potential to significantly improve the ability of CART cells to recognize and kill lymphoma cells without a significant impact on safety. Participants will receive the tazemetostat pills before and after receiving their CAR T cell therapy, for up to 12 months after CAR T cell administration. Patients will be followed for up to 5 years.

Official Title

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

Quick Facts

Study Start:2023-10-04
Study Completion:2031-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05934838

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of DLBCL, FL, or MCL
  2. * Eligible to receive standard of care CAR T cells
  3. * Have received at least 1 prior therapies
  1. * Active viral infection with HIV or hepatitis type B or C
  2. * Active, uncontrolled systemic fungal, bacterial or viral infection
  3. * Active treatment for another cancer
  4. * Pregnant or breastfeeding
  5. * Unable to take oral medication
  6. * Certain significant past medical history, such recent stroke, pulmonary embolism, myocardial infarction, congestive heart failure, uncontrolled hypertension, or certain arrhythmias

Contacts and Locations

Study Contact

Nicole Santos
CONTACT
646-962-6827
nis7058@med.cornell.edu
Samuel Yamshon, MD
CONTACT
646-962-7950
sjy9001@med.cornell.edu

Principal Investigator

Samuel Yamshon, M.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Samuel Yamshon, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-04
Study Completion Date2031-09

Study Record Updates

Study Start Date2023-10-04
Study Completion Date2031-09

Terms related to this study

Keywords Provided by Researchers

  • CAR T-cell
  • Tazemetostat
  • FL
  • MCL
  • DLBCL

Additional Relevant MeSH Terms

  • Follicular Lymphoma
  • B-Cell Lymphoma
  • Mantle Cell Lymphoma
  • Diffuse Large B Cell Lymphoma