RecruitingRefractory Diffuse Large B Cell Lymphoma (DLBCL)Relapsed Diffuse Large B Cell LymphomaHigh Grade B-cell Lymphoma (HGBCL)

DALY II USA/ MB-CART2019.1 for DLBCL

Eligible age

18+ yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

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About this study

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 B cell lymphoma (BCL). Cohorts include subjects with diffuse large B-cell lymphoma (DLBCL) after receiving at least 2 lines of therapy, primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL) after receiving at least one line of therapy, mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy, and DLBCL transplant-ineligible after receiving at least one line of therapy.

Sponsor: Miltenyi Biomedicine GmbH

You may qualify if…

✓ Histologically confirmed B-cell non-Hodgkin's lymphoma:
✓ DLBCL cohort (both cohorts)
✓ DLBCL or associated subtype, defined by WHO 2016 classification
✓ 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
✓ Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3)

You may not qualify if…

✕ Primary CNS lymphoma (not applicable to CNS cohort)
✕ Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL) (not applicable to RT cohort)
✕ Unable to give informed consent
✕ Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive). If there is a history of treated hepatitis B or hepatitis C, the viral load must be quantitative polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-HBc positive
✕ Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and/or nucleic acid testing.
✕ Pharmacologically uncontrolled seizures.
✕ Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis, or other immunologic or inflammatory disease
✕ Presence of CNS disorder that, in the judgment of the Investigator, may impair the ability to evaluate neurotoxicity. For CNS Cohort: