RecruitingPhase 2NCT05934448

Pembro Plus CAR T-cell Therapy in R/R in PMBCL

A Phase II Trial of Pembrolizumab in Combination With Chimeric Antigen Receptor Therapy in Patients With Relapsed/Refractory Primary Mediastinal B-cell Lymphoma


Sponsor

Jennifer Crombie, MD

Enrollment

35 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment. The names of the study drugs involved in this study are: \- Pembrolizumab Standard treatment will include: * CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel) * Cyclophosphamide * Fludarabine


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug pembrolizumab (also known as Keytruda) to CAR T-cell therapy (a type of personalized immune cell treatment) improves outcomes in people with certain types of aggressive B-cell lymphomas that have returned or stopped responding to treatment. **You may be eligible if...** - You have a confirmed diagnosis of PMBCL (primary mediastinal B-cell lymphoma), EBV+ DLBCL, or THRLBCL - You are eligible to receive standard CAR T-cell therapy - Your cancer progressed after at least two prior treatment regimens, or you relapsed within 12 months of first-line therapy, or you are not a candidate for stem cell transplant - You are in good health with a heart ejection fraction of at least 50% (ECOG 0–1) **You may NOT be eligible if...** - You have active HIV, hepatitis B or C - You have an active uncontrolled infection (fungal, bacterial, or viral) - You are being treated for another active cancer - You are pregnant or breastfeeding - You have significant heart, lung, or other major organ problems 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

DRUGPembrolizumab

Pembrolizumab via iv, dosage and timing per protocol

DRUGLymphodepletion Chemotherapy

Participants will undergo lymphodepleting chemotherapy (fludarabine, cyclophosphamide) for CAR T-cell therapy as per SOC

DRUGChimeric Antigen Receptor (CAR) Therapy Infusion

Day 0 in the hospital and will remain in the inpatient setting for observation for a minimum of 7 days or until CAR T-cell toxicities resolve to grade 1 or better. The choice of CAR-T product will be left to the discretion of the treating investigator.

PROCEDURELeukapheresis

manufacturing using commercial product as per standard of care (SOC) Cycle 1 Day -21 or earlier


Locations(2)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05934448


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