DALY II USA/MB-CART2019.1 for Relapsed/Refractory B-cell Lymphoma
This study is testing a new type of cell therapy called zamtocabtagene autoleucel (MB-CART2019.1) for people with certain types of B-cell lymphoma that have come back or haven't responded to previous treatments. This therapy uses your own immune cells, called T cells, which are specially modified to fight cancer. Before receiving these modified cells, you will get chemotherapy (cyclophosphamide and fludarabine, or bendamustine) to prepare your body. The study aims to see how many people respond to this treatment. You might be able to join if you are 18 or older and have diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed lymphoma that has relapsed or is refractory after at least two prior treatments. The current status of this study is unclear.
- Study design
- This is a Phase 2 study, meaning it's evaluating the treatment's effectiveness and safety in a larger group of people. It is a single-arm study, meaning all participants receive the same treatment, and it plans to enroll 315 participants.
- What's involved
- After screening, you will have a procedure called leukapheresis to collect your cells. You will then receive chemotherapy before getting the zamtocabtagene autoleucel (MB-CART2019.1) infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 2 years to check for treatment effectiveness and safety.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04792489
DALY II USA/ MB-CART2019.1 for DLBCL
Recruiting
PHASE2Ages 18+InterventionalTreatmentMiltenyi Biomedicine GmbH
~315 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:zamtocabtagene autoleucel (MB-CART2019.1)CyclophosphamideFludarabineBendamustine
At a glance
Recruiting sites
30 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate
Measured over through study completion, up to 2 years
Conditions
NCT04792489
Where you'd take part
This study runs at 32 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizonastudy coordinator listed
Recruiting
Baptist Health Miami Cancer Institute
Miami, Floridastudy coordinator listed
Recruiting
Colorado Blood Cancer Institute
Denver, Coloradostudy coordinator listed
Recruiting
Dana Farber Cancer Institute
Boston, Massachusettsstudy coordinator listed
Recruiting
Duke University Medical Center - Division of Hematologic Malignancies
Durham, North Carolinastudy coordinator listed
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washingtonstudy coordinator listed
Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsinstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Johanna Theruvath, MD · STUDY_DIRECTOR · Miltenyi Biomedicine GmbH
Who to contact
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Eligibility criteria
Inclusion
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)
B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)
Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation
Histologically confirmed 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:
Chemotherapy-refractory disease (applies to all cohorts) is defined as persistent disease after last line of therapy or relapsed or persistent disease after prior ASCT for lymphoma
Disease relapse in subjects without prior ASCT is defined as relapse of disease after the last dose of most recent therapy regimen
First-line therapy is defined as either high dose methotrexatebased therapy, temozolomide, high dose cytarabine, pemetrexed, lenalidomide or Bruton tyrosine kinase (BTK) inhibitor-based therapy.
No contraindications for MRI evaluation
CNS cohort: Subjects with SCNSL must have relapsed or refractory disease after having received at least one prior line of systemic therapy
Prior lines of systemic therapy should include an anti-CD20 monoclonal antibody and anthracycline containing chemotherapy regimen and/or with or without an autologous stem cell transplant
Cytotoxic rituximab \[or equivalent\] based chemotherapy regimen (eg, rituximab bendamustine, R-CHOP, R-DHAP, R-ARA-C) AND
BTK inhibitor
For this cohort subjects are considered transplant ineligible if they meet one of the following criteria:
Age ≥70 years
ECOG status is 2 at screening
Impaired pulmonary function: diffusing capacity of the lung for carbon monoxide \[DLCO\] ≤ 60% adjusted for gender-specific hemoglobin concentration (Coates formula)
Impaired cardiac function: left ventricular ejection fraction (LVEF) \< 50%; must be assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 4 weeks of determination of eligibility
Impaired renal function: calculated creatinine clearance (Cockcroft and Gault) \< 60 mL/min
Impaired hepatic function: aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 x upper limit of normal (ULN)
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to lymphoma
Subjects in DLBCL transplant-ineligible 2nd-line cohort with ECOG performance status of 2, regardless of attribution, will be allowed for inclusion
Measurable disease will be assessed by FDG-PET/CT in systemic lymphoma . and by brain/spine MRI for CNS disease
Subject must have a tumor biopsy sample (at least 16 unstained slides of tissue or tissue block) from the most recent relapse available prior to MB-CART2019.1 infusion. If medically not feasible to obtain a biopsy from the most recent relapse and for cases when the amount of tissue is limited, the sponsor should be consulted, to confirm adequacy of the sample for study required analyses
No clinical suspicion of central nervous system (CNS) lymphoma (not applicable to CNS cohort)
Subjects in DLBCL transplant-ineligible 2nd-line cohort with SCNSL will be allowed for inclusion
If the subject has history of CNS disease (not applicable to CNS cohort), then he/she must have no signs or symptoms of CNS disease, have no active disease on magnetic resonance imaging (MRI), have no large cell lymphoma present in cerebral spinal fluid (CSF), regardless of the number of white blood cells (WBCs)
If has history of cerebral vascular accident (CVA), the CVA event must be greater than 12 months prior to leukapheresis. Any neurological deficits must be stable
A creatinine clearance (as estimated by direct urine collection or Cockcroft-Gault Equation) \> 45mL/min
Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA)
Subjects in DLBCL transplant-ineligible 2nd-line cohort with a lower ejection fraction of \> 40% will be allowed for inclusion
Resting O2 saturation \>90% on room air
Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST)\<5 times the Upper Limit of Normal (ULN) for age
Total bilirubin \<1.5 mg/dl, except in individuals with Gilbert's syndrome
Subjects in DLBCL transplant-ineligible 2nd-line cohort with a total bilirubin of \< 2.0 mg/dL will be allowed for inclusion
Absolute neutrophil count (ANC) \> 1000/μL
Absolute lymphocyte count \> 100/μL
Platelet count \> 50,000/µL
Estimated life expectancy of more than 3 months other than primary disease
Exclusion
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:
For CNSL and DLBCL transplant-ineligible 2nd-line cohort patients that have a CNS lesion(s): Midline shift on MRI or Abnormal high CSF opening pressure and or CSF protein ≥150 mg/dL Recent (within 3 months) whole brain radiotherapy (WBRT) are exclusionary
Active systemic fungal, viral, or bacterial infection
Pregnant or breast-feeding woman
Previous or concurrent malignancy with the following exceptions:
Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to study entry)
In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study
Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years
A primary malignancy which has been completely resected / treated with curative intent and in complete remission of ≥ 2 years
Severely immunocompromised subjects e.g., due to current treatment of non-neurologic autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
Medical condition requiring prolonged use of systemic corticosteroids equivalent to prednisone \>10 mg/day. For CNS cohort: Up to 2 mg/day dexamethasone (or equivalence) may be allowed at any time, higher doses allowed up to 7 days prior to apheresis or after apheresis until lymphodepletion.
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.
Concurrent radiotherapy (allowed up to time of lymphodepletion). For prior systemic therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis.
Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline.
History of severe immediate hypersensitivity reaction to any of the agents used in this study.
Refusal to participate in additional lentiviral gene therapy long-term follow-up (LTFU) protocol
Prior CAR-T therapy for any indication or systemic gene modifying therapy for B-cell lymphoma
Prior allogeneic stem cell transplant for any indication
Prior Bispecific T cell engaging (BITE) antibodies for cancer therapy
Prior T cell receptor-engineered T cell therapy
What this trial measures
- Objective Response Ratethrough study completion, up to 2 years
ORR