Study on Pembrolizumab Plus CAR T-cell Therapy for Relapsed or Refractory Primary Mediastinal B-cell Lymphoma

Sponsor: Jennifer Crombie, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05934448

Provider View

This clinical trial is exploring a new treatment combination of pembrolizumab and CAR T-cell therapy for patients with primary mediastinal B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is testing a combination of pembrolizumab and CAR T-cell therapy as a potential treatment for primary mediastinal B-cell lymphoma (PMBCL) that has come back or not responded to earlier treatments. The study will also include standard treatments like cyclophosphamide and fludarabine. Participants will receive treatment for up to 2 years and be monitored for 5 years. About 35 people are expected to join this study.

Description

This is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment. The study involves using pembrolizumab, a drug approved by the FDA for this type of lymphoma after other treatments have failed, but not in combination with CAR T-cell therapy. The CAR T-cell therapies used in this study are axicabtagene-ciloleucel and lisocabtagene maraleucel, which are also FDA-approved for this disease but not with pembrolizumab. A small group of patients with other related lymphomas will also be included. Participants will receive treatment for up to 2 years and be followed for 5 years to monitor their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary mediastinal B-cell lymphoma (PMBCL), EBV+ large B-cell lymphoma, or T-cell histiocyte-rich large B-cell lymphoma.
  • Must provide a tumor sample before joining the study.
  • Eligible for standard CAR T-cell therapy after at least two previous treatments, or if the cancer is resistant to initial treatment, or if it returns within 12 months of first treatment.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Heart function with an ejection fraction of 50% or higher.
  • Adequate blood cell counts and organ function.
  • At least one measurable lymphoma lesion on a PET/CT scan.
  • Women of childbearing potential and men must agree to use effective birth control during the study and for 6 months after treatment.
  • Aged 18 years or older.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Urgent need for treatment to reduce tumor size.
  • Receiving other experimental treatments.
  • History of other cancers, unless treated and inactive for 2 years.
  • Recent live vaccine within 30 days.
  • Less than 6 months response to previous PD-L1 or PD-1 inhibitors.
  • Previous CAR T-cell therapy.
  • Pregnant or breastfeeding women.
  • Active lymphoma in the central nervous system.
  • Recent serious infection or uncontrolled infection.
  • History of hepatitis B or C, or HIV.
  • Recent radiotherapy or systemic cancer treatment.
  • Significant liver disease or previous severe immune reactions.
  • Uncontrolled heart conditions or recent heart attack.
  • History of brain disease or recent stroke.
  • Previous organ or stem cell transplant.
  • Active autoimmune disease needing treatment in the past 2 years.
  • Taking high-dose steroids or immunosuppressive drugs.
  • Active lung disease or severe allergy to pembrolizumab.
  • Any condition that could interfere with the study or participant's safety.
  • Psychiatric or substance abuse issues affecting study participation.

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