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Refractory Diffuse Large B Cell Lymphoma (DLBCL)Phase 2NCT04792489

DALY II USA/ MB-CART2019.1 for DLBCL

A Phase 2 study testing zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide and Fludarabine in people with Refractory Diffuse Large B Cell Lymphoma (DLBCL) and Relapsed Diffuse Large B Cell Lymphoma, run by Miltenyi Biomedicine GmbH at 32 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 B cell lymphoma (BCL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
32 sitesin 2 countries
Study dates
25 May 2021to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • Primary mediastinal (thymic) large B cell lymphoma
  • Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3)
  • o CNS cohort
  • B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)
  • o Mantle Cell Lymphoma (MCL) cohort
  • Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation
  • o Richter's Transformation (RT) cohort
  • 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:
  • For DLBCL cohort (after receiving at least two prior lines of therapy): persistent disease after failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either after failed ASCT, or ineligible, not intended for or not consenting to ASCT
  • 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
  • For disease specific cohorts added after the initial DLBCL cohort the definition of relapsed/refractory disease is as described below:
  • CNS cohort: Subjects with relapsed/refractory PCNSL that have failed (or unable to tolerate) at least first-line therapy.
  • 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
  • MCL cohort: Subjects with relapsed/refractory disease after at least one prior systemic treatment, that must include:
  • Cytotoxic rituximab [or equivalent] based chemotherapy regimen (eg, rituximab bendamustine, R-CHOP, R-DHAP, R-ARA-C) AND
  • BTK inhibitor
  • RT cohort: Subject must have relapsed/refractory disease after at least one prior systemic treatment following Richter's Transformation
  • DLBCL transplant ineligible 2nd cohort: subject must have failure of first-line chemotherapy (including rituximab or equivalent and anthracycline).
  • 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)
  • In addition, all subjects must have:
  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Ron Gomez contact

617-218-0044

clinicaltrials@miltenyi.com

Harshita Gahankari contact

617-218-0044

clinicaltrials@miltenyi.com

32 sites in 2 countries

United States30 sites, 28 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Maria Hollobaugh, mholloba@med.umich.edu

    Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Amelia Langston, MD, alangst@emory.edu

    Recruiting

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

    Vamsi Kota, MD, vkota@augusta.edu

    Recruiting

  • University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

    Nancy Hardy, MD, nhardy1@umm.edu

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Antwain Johnson, antwaindjohnson@uabmc.edu

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Obed Posada Villanueva, Obed_villanueva@DFCI.HARVARD.EDU

    Recruiting

  • Robert H Lurie Cancer Center

    Chicago, Illinois, 60611

    Reem Karmali, MD, reem.karmali@northwestern.edu

    Recruiting

  • The Ohio State University Wexner Medical Center James Cancer

    Columbus, Ohio, 43210

    Nathan Denlinger, DO, nathan.denlinger@osumc.edu

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Farrukh Awan, MD, Farrukh.awan@utsouthwestern.edu

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Luke Mountjoy, MD, luke.mountjoy@healthonecares.com

    Recruiting

  • Duke University Medical Center - Division of Hematologic Malignancies

    Durham, North Carolina, 27705

    Matthew S. McKinney, MD, Matthew.mckinney@duke.edu

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Yasmin Adam, Yasmin.Adam2@bannerhealth.com

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Luhua (Michael) Wang, MD, Miwang@mdanderson.org

    Recruiting

  • UC San Diego Health

    La Jolla, California, 92037

    Dimitrios Tzachanis, MD, dtzachanis@health.ucsd.edu

    Recruiting

  • Baptist Health Miami Cancer Institute

    Miami, Florida, 33176

    Sueanna Sukie, Sueanna.Sukie@baptisthealth.net

    Recruiting

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Jessica Eisenhauer, jeisenhauer@mcw.edu

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Krish Patel, MD, krish.patel@scri.com

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Jialing Zhang, jialing.zhang@yale.edu

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Miguel-Angel Perales, MD, peralesm@mskcc.org

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Terminated

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Allison Rosenthal, DO, Rosenthal.Allison@mayo.edu

    Recruiting

  • Allegheny Health Network Cancer Institute

    Pittsburgh, Pennsylvania, 15212

    John Lister, MD, john.lister@ahn.org

    Recruiting

  • University of Pittsburgh - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15260

    Withdrawn

  • Oregon Health and Science University Knight Cancer Institute

    Portland, Oregon, 97239

    Richard Maziarz, MD, maziarzr@ohsu.edu

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Patrick Johnston, MD, johnston.patrick@mayo.edu

    Recruiting

  • Texas Transplant Institute

    San Antonio, Texas, 98109

    Timothy Fenske, MD, timothy.fenske@hcahealthcare.com

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Jordan Gauthier, MD, jgauthier@fredhutch.org

    Recruiting

  • Washington University, St. Louis

    St Louis, Missouri, 63110

    Amanda Cashen, MD, acashen@wustl.edu

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Christina Tran, ctran13@stanford.edu

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

    Sunil Abhyankar, MD, sabhyankar@kumc.edu

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • University of Alberta Cross Cancer Institute

    Edmonton, Alberta, AB T6G 1Z2

    Michael Chu, MD, michael.chu@albertahealthservices.ca

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, ON M5G 2C4

    John Kuruvilla, John.Kuruvilla@uhn.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

A prospective, single arm, open label, multi-center, phase II study of autologous T cells engineered against both CD19 and CD20 antigens for subjects with relapsed or refractory DLBCL after receiving at least two lines of therapy. The investigational agent is the MB-CART2019.1 cells. Additional cohorts include transplant-ineligible subjects with relapsed and/or refractory DLBCL after first-line therapy (i.e. DLBCL transplant-ineligible 2nd-line), r/r 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. After successful screening, subjects will undergo leukapheresis to collect product for manufacturing. In preparation for the fresh product infusion, subjects will undergo a lymphodepleting regimen with cyclophosphamide and fludarabine, or bendamustine. Cell infusion will be administered intravenously at a dose of 2.5 x 106 CAR+ cells/kg body weight. The study will start with enrollment of 3 subjects in the lead-in safety phase, and after safety is evaluated, the study will continue with enrollment of the remaining subjects. Subjects will be followed for up to 2 years, for efficacy and safety outcomes as well as health-related quality of life (HRQol). Additional long-term follow-up will be conducted for participants under a separate long-term follow-up protocol.

Being tested
zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide, Fludarabine, Bendamustine
Keywords
CD19/CD20-directed CAR-T Cells, Zamtocabtagene autoleucel, B-Cell Non-Hodgkin Lymphoma, Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma, NHL, PCNSL, SCNSL, Chimeric Antigen Receptor, CAR, CAR-T Cell, Autologous T Cell Therapy, Central Nervous System Neoplasms, Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, MCL, RT, CLL
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Central Nervous System Neoplasms, Lymphoma, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zamtocabtagene autoleucel (MB-CART2019.1)Biological

    Chimeric antigen receptor (CAR) T cell therapy

  • CyclophosphamideDrug

    Lymphodepleting chemotherapy

  • FludarabineDrug

    Lymphodepleting chemotherapy

  • BendamustineDrug

    Lymphodepleting chemotherapy

Study groups in NCT04792489
Study groupRoleWhat they receive
Single, open labelExperimentalNot described
Receives: Biological: zamtocabtagene autoleucel (MB-CART2019.1); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    ORR

    Measured: through study completion, up to 2 years

Secondary outcomes (15)

  1. Complete Response Rate

    CRR

    Measured: 1 and 6 months

  2. Duration of Response

    DOR

    Measured: Up to 2 years

  3. Overall Response Rate

    ORR

    Measured: 1 and 6 months

  4. Best Overall Response

    BOR

    Measured: 2 years

  5. Duration of Complete Response

    DOCR

    Measured: 2 years

  6. Progression Free Survival

    PFS

    Measured: Up to 2 years

  7. Overall Survival

    OS

    Measured: Up to 2 years

  8. Type, frequency, and severity of adverse events

    Safety

    Measured: Up to 2 years

  9. Incidence of anti-MD-CART2019.1 antibodies

    Bioanalytical

    Measured: Up to 2 years

  10. Phenotype of MB-CART2019.1

    Bioanalytical

    Measured: Up to 2 years

  11. Persistence of MB-CART2019.1

    Bioanalytical

    Measured: Up to 2 years

  12. Quality of Life (QoL) assessments [EQ-5D-5L]

    Health Outcomes - Standardized 5 question measure of health status developed by the EuroQol Group

    Measured: Up to 2 years

  13. Patient-Reported Outcome (PRO) assessment [FACT-Lym]

    Health Outcomes - To address health-related quality-of-life (HRQL) issues for Non-Hodgkin's lymphoma (NHL) patients

    Measured: Up to 2 years

  14. Pharmacodynamics [Levels of cytokines in blood]

    Bioanalytical

    Measured: Up to 2 years

  15. Correlation of tumor CD19 and CD20 antigen expression with disease progression and relapse

    Bioanalytical

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start25 May 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
315 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792489
Sponsor's protocol ID
M-2018-344
Status last verified
Jul 2026
First submitted
25 Feb 2021
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide and Fludarabine in people with Refractory Diffuse Large B Cell Lymphoma (DLBCL) and Relapsed Diffuse Large B Cell Lymphoma, run by Miltenyi Biomedicine GmbH at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 57 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ron Gomez (617-218-0044, clinicaltrials@miltenyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: through study completion, up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04792489.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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