NCT05934448

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Jennifer Crombie, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. 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 Participants will receive study treatment for up to 2 years and will be followed for 5 years. It is expected that about 35 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for this specific disease after two or more lines of therapy, but not in combination with CAR T-cell therapy. The CAR T-cell therapies to be used in this study are axicabtagene-ciloleucel and lisocabtagene maraleucel. The U.S. FDA has approved axicabtageneciloleucel and lisocabtagene maraleucel as treatment options for this disease, but not in combination with pembrolizumab. A small subset of patients with T-cell histiocyte-rich large B-cell lymphoma and EBV+ large B-cell lymphoma will also be included.

Conditions

• Primary Mediastinal Large B-cell Lymphoma (PMBCL)
• Primary Mediastinal Large B Cell Lymphoma
• Primary Mediastinal Large B-Cell Lymphoma Refractory
• Primary Mediastinal Large B-Cell Lymphoma Recurrent
• Epstein-Barr Virus Positive Diffuse Large B-Cell Lymphoma
• T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab via iv, dosage and timing per protocol
DRUG	Lymphodepletion Chemotherapy	Participants will undergo lymphodepleting chemotherapy (fludarabine, cyclophosphamide) for CAR T-cell therapy as per SOC
DRUG	Chimeric 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.
PROCEDURE	Leukapheresis	manufacturing using commercial product as per standard of care (SOC) Cycle 1 Day -21 or earlier

Timeline

• Start date: 2023-11-15
• Primary completion: 2027-06-06
• Completion: 2031-06-06
• First posted: 2023-07-07
• Last updated: 2026-03-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study