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Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients

Study acronym: DALY 2-EU
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 52 to 51v29
  2. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 45 to 213 · Interventions: MB-CART2019.1 (Genetic) to MB-CART2019.1 (Genetic), Standard of Care (Drug) · Site details revised at 52 of 52 sites · 1 morev28 Show 4 more changesShow less
    • Enrollment target: 45 to 213
    • Interventions: MB-CART2019.1 (Genetic) to MB-CART2019.1 (Genetic), Standard of Care (Drug)
    • Site details revised at 52 of 52 sites
    • Study arms: 1 to 3
  3. Enrollment target: 168 to 45 Primary endpoints: 1 to 2 · Study sites: 53 to 52 · Completion date: Jul 31, 2029 to Sep 30, 2031 · 5 morev27 Show 8 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 53 to 52
    • Completion date: Jul 31, 2029 to Sep 30, 2031
    • Interventions: MB-CART2019.1 (Genetic), R-GemOx or BR plus polatuzumab vedotin (Drug) to MB-CART2019.1 (Genetic)
    • Eligibility criteria expanded, about 1,284 words
    • Secondary endpoints: 4 to 9
    • Study description expanded, about 87 words
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date changed from estimate of Dec 31, 2024 to Jan 15, 2025v26
  5. Study sites: 54 to 53 Completion date: Jul 31, 2027 to Jul 31, 2029v25 Show 1 more changeShow less
    • Completion date: Jul 31, 2027 to Jul 31, 2029
Show 23 earlier versionsHide 23 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 54 of 54 sitesv24 Show 1 more changeShow less
    • Site details revised at 54 of 54 sites
  2. Study sites revised (54)v23 See this version in full on ClinicalTrials.gov ↗
  3. Study description revisedv22 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Dec 31, 2023 to Dec 31, 2024 Primary endpoint revised · Study sites: 73 to 54 · Completion date: Dec 31, 2024 to Jul 31, 2027 · 3 morev21 Show 6 more changesShow less
    • Primary endpoint revised
    • Study sites: 73 to 54
    • Completion date: Dec 31, 2024 to Jul 31, 2027
    • Eligibility criteria expanded, about 192 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 78 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 69 to 73v20
  6. Study sites: 65 to 69v19
  7. Study sites: 53 to 65v18
  8. Study sites: 51 to 53v17
  9. Site details revised at 3 of 51 sitesv16
  10. Study sites: 53 to 51 Primary completion date: Sep 30, 2023 to Dec 31, 2023 · Completion date: Sep 30, 2024 to Dec 31, 2024v15 Show 2 more changesShow less
    • Primary completion date: Sep 30, 2023 to Dec 31, 2023
    • Completion date: Sep 30, 2024 to Dec 31, 2024
  11. Study sites: 56 to 53v14
  12. Study sites: 55 to 56v13
  13. Study sites: 38 to 55 Study description shortened, about 1 wordv12 Show 1 more changeShow less
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 35 to 38v11
  15. Study sites: 34 to 35v10
  16. Re-verified, no change to tracked fieldsv9
  17. Study sites: 30 to 34v8
  18. Study sites: 25 to 30v7
  19. Study sites: 20 to 25v6
  20. Study sites: 19 to 20v5
  21. Study sites: 13 to 19v4
  22. Study sites: 1 to 13v3
  23. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 30, 2021 to Aug 18, 2021 · Study sites: 0 to 1 · Primary completion date: Jun 30, 2023 to Sep 30, 2023 · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of Apr 30, 2021 to Aug 18, 2021
    • Study sites: 0 to 1
    • Primary completion date: Jun 30, 2023 to Sep 30, 2023
    • Completion date: Jun 30, 2024 to Sep 30, 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. Part II is a Phase II single-arm, open-label, multi-centre study evaluating the efficacy and safety of MB-CART2019.1 in younger, fit participants with R-R DLBCL. Part II will start after completion of enrolment in Part I.
Trial Details
NCT Number NCT04844866
Lead Sponsor Miltenyi Biomedicine GmbH
Collaborators: ICON plc
Conditions Diffuse Large B-cell Lymphoma
Enrollment 213 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov