Trials / Recruiting
RecruitingNCT07288879
DALY II Japan/MB-CART2019.1 for DLBCL
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.
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- Sponsor
- Miltenyi Biomedicine GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
DALY II Japan 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.
Detailed description
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. Cell infusion will be administered intravenously at a dose of 2.5 x 10\^6 CAR+ cells/kg body weight. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MB-CART2019.1 | CAR T cell therapy |
Timeline
- Start date
- 2025-12-11
- Primary completion
- 2027-01-31
- Completion
- 2028-12-31
- First posted
- 2025-12-17
- Last updated
- 2026-01-08
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT07288879. Inclusion in this directory is not an endorsement.