Pembro Plus CAR T-cell Therapy in R/R in PMBCL
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 treat
| Condition(s) | 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, |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: * Histologically confirmed diagnosis of PMBCL, EBV+ DLBCL or THRLBCL at one of the participating institutions. * Availability of archival or freshly collected tumor tissue before study enrollment. If archival tissue is unavailable or is determined to be inadequate, tumor tissue must be obtained from a biopsy performed at screening, unless an exception is given after consultation with the sponsor-investigator. * Eligible for standard of care CAR T-cell therapy with progression after at least two prior lines of therapy OR refractory to initial chemoimmunotherapy OR relapse within 12 months of front-line chemoimmunotherapy OR one prior line of therapy and not fit for HSCT. * ECOG Performance Status of 0 or 1. * Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac mul |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Jennifer Crombie, MD |
| Locations | Boston, Massachusetts, United States; New York, New York, United States |
| Start date | 2023-11-15 |
| NCT ID | NCT05934448 |
| Official listing | https://clinicaltrials.gov/study/NCT05934448 |