Marginal zone lymphoma is an indolent B-cell non-Hodgkin lymphoma arising from the marginal zone of lymphoid tissue. It includes extranodal, nodal, and splenic subtypes and usually follows a slow-growing clinical course.
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
The cell therapy manufacturing market is projected to reach $14.01 billion by 2035, with CAR-T therapies dominating at 65% market share. Recent FDA approvals for new CAR-T indications and Japanese regulatory acceleration highlight growing clinical adoption, while research advances include new anti-aging protein platforms and CRISPR-based treatments.
The FDA has approved Bristol Myers Squibb's CAR-T therapy Breyanzi for relapsed/refractory marginal zone lymphoma, while a novel multiple myeloma drug candidate DTP3 advances to Phase 2 trials after showing promising early results. Both developments represent significant progress in blood cancer treatment, with the marginal zone lymphoma approval based on a 95.5% response rate and the myeloma drug demonstrating selective cancer cell killing without toxicity.
Recent studies demonstrate zanubrutinib delivers higher response rates, longer treatment persistence, and lower healthcare costs compared to acalabrutinib and ibrutinib across multiple B-cell malignancies, with particularly strong benefits in high-risk populations.
Phase 2 trial data show lisocabtagene maraleucel achieved a 95% overall response rate in patients with relapsed or refractory marginal zone lymphoma, with a manageable safety profile and no new safety signals.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07583810 |
Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07441993 |
Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL |
RECRUITING | PHASE2 |
| NCT07233720 |
Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma |
RECRUITING | |
| NCT07225439 |
Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) |
NOT_YET_RECRUITING | PHASE1 |
| NCT07168486 |
CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas |
ENROLLING_BY_INVITATION | PHASE1 |
| NCT07029217 |
A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas |
RECRUITING | PHASE3 |
| NCT06860880 |
Combating Cancer-Related Fatigue: A Personalized Supportive Care Program |
RECRUITING | NA |
| NCT06796998 |
Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL) |
RECRUITING | PHASE2 |
| NCT06792825 |
HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL |
RECRUITING | PHASE2 |
| NCT06636175 |
64Cu-LLP2A for Imaging Hematologic Malignancies |
RECRUITING | EARLY_PHASE1 |
