Central Nervous System Lymphoma Clinical Trial
Official title:
A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and/or Refractory Diffuse Large B Cell Lymphoma
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.
A prospective, single arm, open label, multi-center, phase II study of autologous T cells engineered against both CD19 and CD20 antigens for subjects with relapsed or refractory DLBCL after receiving at least two lines of therapy. The investigational agent is the MB-CART2019.1 cells. After successful screening, subjects will undergo leukapheresis to collect product for manufacturing. In preparation for the fresh product infusion, subjects will undergo a lymphodepleting regimen with cyclophosphamide and fludarabine, or bendamustine. Cell infusion will be administered intravenously at a dose of 2.5 x 106 CAR+ cells/kg body weight. The study will start with enrollment of 3 subjects in the lead-in safety phase, and after safety is evaluated, the study will continue with enrollment of the remaining subjects. Subjects will be followed for up to 2 years, for efficacy and safety outcomes as well as health-related quality of life (HRQol). Additional long-term follow-up will be conducted for participants under a separate long-term follow-up protocol. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04516655 -
A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients
|
Phase 2 | |
| Recruiting |
NCT05054426 -
Intermediate Dose of IV MTX as CNS Prophylaxis for High Risk DLBCL
|
Phase 3 | |
| Recruiting |
NCT02623010 -
Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma
|
Phase 2 | |
| Recruiting |
NCT04548648 -
A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas
|
Phase 2 | |
| Active, not recruiting |
NCT00293475 -
Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT03342586 -
Using a Novel Functional MRI Technique to Evaluate for Neurotoxicity
|
||
| Terminated |
NCT02420795 -
Akt/ERK Inhibitor ONC201 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01011920 -
Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
|
Phase 2 | |
| Completed |
NCT00967200 -
Study of Tissue Samples From Patients With Glioma or Other Brain Tumors
|
N/A | |
| Recruiting |
NCT03684980 -
LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma
|
Early Phase 1 | |
| Not yet recruiting |
NCT06213636 -
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04938297 -
Rituximab,Zanubrutinib in Combination With Lenalidomide, Followed by Zanubrutinib or Lenalidomide Maintenance in Patients With Primary or Secondary CNS Lymphoma
|
Phase 2 | |
| Completed |
NCT01458730 -
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
|
Phase 2 | |
| Completed |
NCT00153530 -
Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)
|
Phase 4 | |
| Recruiting |
NCT04186520 -
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05816746 -
Decitabine and Anti-PD-1 in R/R DLBCL
|
Phase 2 | |
| Recruiting |
NCT06031194 -
Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma
|
||
| Active, not recruiting |
NCT03962127 -
MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway
|
||
| Completed |
NCT03690895 -
Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy
|
||
| Recruiting |
NCT05114330 -
Secondary Central Nervous System Lymphoma Registry - Charité
|