DALY II Japan/MB-CART2019.1 for DLBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMiltenyi Biomedicine GmbH
About this trial
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.
Eligibility criteria
Qualifiers
DLBCL not otherwise specified (NOS)
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
High-grade B-cell lymphoma, NOS
Primary mediastinal (thymic) large B-cell lymphoma
Disqualifiers
Primary CNS lymphoma
Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL)
Unable to give informed consent
Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive), unless confirmed to be polymerase chain reaction (PCR) negative; antiviral prophylaxis is required as recommended in the Japanese guidelines for Hepatitis B treatment if HBsAg negative and anti-HBc positive
Trial design
Treatments tested in this trial
- MB-CART2019.1
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov