NCT04792489 · Miltenyi Biomedicine GmbH
DALY II USA/ MB-CART2019.1 for DLBCL
What this study is about
DALY II USA is a phase II, multi-center, single treatment group$1 study to evaluate the effectiveness, safety, and how the drug moves through the body 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.
View original scientific description
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.
Interventions
BIOLOGICAL
zamtocabtagene autoleucel (MB-CART2019.1)
Chimeric antigen receptor (CAR) T cell therapy
DRUG
Cyclophosphamide
Lymphodepleting chemotherapy
DRUG
Fludarabine
Lymphodepleting chemotherapy
DRUG
Bendamustine
Lymphodepleting chemotherapy
Primary outcome measures
Objective Response Rate
Time frame: through study completion, up to 2 years
ORR
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically confirmed B-cell non-Hodgkin's lymphoma:
- DLBCL 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)
- CNS Cohort only: B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)
- Mantle Cell Lymphoma (MCL) Cohort: Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation
- Richter's Transformation (RT) Cohort: Histologically confirmed Richter's transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype from underlying CLL (clonally related)
- Relapsed or refractory disease is defined for DLBCL (and associated subtypes) population as fa
Where
- Birmingham, Alabama
- Gilbert, Arizona
- Phoenix, Arizona
- La Jolla, California
- Stanford, California
- Denver, Colorado
- New Haven, Connecticut
- Miami, Florida
- Atlanta, Georgia
- Augusta, Georgia
- Chicago, Illinois
- Westwood, Kansas
And 17 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations