RecruitingPhase 2NCT06242834

Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma

Phase II, Single Arm, Open Label, Study of the Combination of Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-Cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma


Sponsor

Northwestern University

Enrollment

32 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well pembrolizumab and tazemetostat work to treat patients who have received autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T cell therapy for aggressive non hodgkins lymphoma. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Tazemetostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and tazemetostat may work better to treat patients who have received ASCT or CAR-T cell therapy for aggressive non hodgkins lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — pembrolizumab (an immunotherapy) and tazemetostat (a targeted therapy) — for people with aggressive B-cell lymphoma who are receiving or planning to receive a stem cell transplant or CAR T-cell therapy. The goal is to see if these drugs can help the immune system work better after these intensive treatments. **You may be eligible if...** - You have been diagnosed with an aggressive form of B-cell non-Hodgkin lymphoma - You are planned for or currently undergoing a stem cell transplant (autologous) or CAR T-cell therapy - Your treatment used one of the approved CAR T-cell products (axicabtagene ciloleucel, tisagenlecleucel, or lisocabtagene maraleucel) - You are generally well enough to tolerate the study treatment **You may NOT be eligible if...** - You have active, uncontrolled autoimmune disease - You are on long-term steroid or immunosuppressive medication - You have serious liver, kidney, or heart problems - You have active infections (such as HIV, hepatitis B or C) - You have had prior treatment with tazemetostat or similar EZH2 inhibitors Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREEchocardiography

Undergo echocardiography

BIOLOGICALPembrolizumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET scan

DRUGTazemetostat

Given PO


Locations(2)

Northwestern University

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

View Full Details on ClinicalTrials.gov

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NCT06242834


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