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

NCT05934448 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-05

No results posted yet for this study

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

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

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

Sponsors & Collaborators

Principal Investigators

  • Jennifer Crombie, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2027-06-06
Completion
2031-06-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05934448 on ClinicalTrials.gov