DALY II USA/ 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
1 other identifier
interventional
248
2 countries
25
Brief Summary
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. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2021
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
May 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 24, 2025
April 1, 2025
5.6 years
February 25, 2021
April 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
ORR
through study completion, up to 2 years
Secondary Outcomes (14)
Complete Response Rate
1 and 6 months
Duration of Response
Up to 2 years
Overall Response Rate
1 and 6 months
Best Overall Response
2 years
Progression Free Survival
Up to 2 years
- +9 more secondary outcomes
Study Arms (1)
Single, open label
EXPERIMENTALInterventions
Chimeric antigen receptor (CAR) T cell therapy
Eligibility Criteria
You may qualify if:
- 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 failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either having failed autologous stem cell transplant (ASCT), or ineligible, not intended for or not consenting to ASCT
- Chemotherapy-refractory disease 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
- CNS Cohort: Subjects with relapsed/refractory PCNSL that have failed (or unable to tolerate) at least first-line therapy.
- No contraindications for MRI evaluation
- +23 more criteria
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:
- Midline shift on MRI
- Abnormal high CSF opening pressure and or CSF protein \>150 mg/dL Recent (within 3 months) whole brain radiotherapy (WBRT)
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
UC San Diego Health
La Jolla, California, 92037, United States
Stanford University
Stanford, California, 94305, United States
Yale University
New Haven, Connecticut, 06520, United States
Baptist Health Miami Cancer Institute
Miami, Florida, 33176, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Robert H Lurie Cancer Center
Chicago, Illinois, 60611, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center - Division of Hematologic Malignancies
Durham, North Carolina, 27705, United States
The Ohio State University Wexner Medical Center James Cancer
Columbus, Ohio, 43210, United States
Oregon Health and Science University Knight Cancer Institute
Portland, Oregon, 97239, United States
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15260, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
University of Alberta Cross Cancer Institute
Edmonton, Alberta, AB T6G 1Z2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, ON M5G 2C4, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johanna Theruvath, MD
Miltenyi Biomedicine GmbH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 11, 2021
Study Start
May 25, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share