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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jennifer Crombie, MD
Study ID
NCT05934448
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 15, 2023
Status verified
Mar 2026
Primary completion
Jun 6, 2027
Completion
Jun 6, 2031

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PEMBROLIZUMAB
    * Participants will undergo (leukapheresis) for manufacturing of commercial product as per standard of care (SOC) Cycle 1 Day -21or earlier * Pembrolizumab will be administered per protocol on cycle 1 day -20 and on day +1 following Chimeric Antigen Receptor (CAR) Therapy Infusion infusion, every 3 weeks for up to 2 years, unless there is confirmed progression of disease or unacceptable toxicity. * Upon the completion of successful manufacturing, patients will undergo lymphodepleting chemotherapy (fludarabine, cyclophosphamide) for chimeric antigen receptor (CAR) therapy infusion as per SOC. * Participants will receive Chimeric Antigen Receptor (CAR) Therapy Infusion (SOC) on 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.

Primary Outcome Measure

Complete Response (CR) Rate at 6 Months [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Clare Phinney
[email protected]
Jennifer Crombie, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Gunjan Shah, MD

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NY

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