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DALY II USA/ MB-CART2019.1 for DLBCL
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.
Details
| Lead sponsor | Miltenyi Biomedicine GmbH |
|---|---|
| Phase | PHASE2 |
| Status | RECRUITING |
| Enrolment | 248 |
| Start date | Tue May 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun Dec 31 2028 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Relapsed Diffuse Large B Cell Lymphoma
- High Grade B-cell Lymphoma (HGBCL)
- Primary Mediastinal B-cell Lymphoma (PMBCL)
- Transformed Lymphoma
- Central Nervous System Lymphoma
- Mantle Cell Lymphoma (MCL)
- Richter Transformation
Interventions
- zamtocabtagene autoleucel (MB-CART2019.1)
- Cyclophosphamide
- Fludarabine
- Bendamustine
Countries
Canada, United States