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DALY II USA/ MB-CART2019.1 for DLBCL

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint revised Enrollment target: 248 to 315 · Study sites: 25 to 32 · Eligibility criteria expanded, about 261 words · 2 morev16 Show 5 more changesShow less
    • Enrollment target: 248 to 315
    • Study sites: 25 to 32
    • Eligibility criteria expanded, about 261 words
    • Secondary endpoints: 14 to 15
    • Study description expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv15
  3. Enrollment target: 110 to 248 Primary completion date: Dec 31, 2024 to Dec 31, 2026 · Study sites: 23 to 25 · Completion date: Dec 31, 2026 to Dec 31, 2028 · 2 morev14 Show 5 more changesShow less
    • Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study sites: 23 to 25
    • Completion date: Dec 31, 2026 to Dec 31, 2028
    • Eligibility criteria expanded, about 214 words
    • Study description expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 20 to 23 Interventions: MB-CART2019.1 (Biological) to Bendamustine (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), zamtocabtagene autoleucel (MB-CART2019.1) (Biological) · Eligibility criteria shortened, about 16 words · Study title revisedv13 Show 3 more changesShow less
    • Interventions: MB-CART2019.1 (Biological) to Bendamustine (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), zamtocabtagene autoleucel (MB-CART2019.1) (Biological)
    • Eligibility criteria shortened, about 16 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Site details revised at 3 of 20 sitesv11
  2. Enrollment target: 65 to 110 Primary completion date: Jul 30, 2023 to Dec 31, 2024 · Study sites: 19 to 20 · Completion date: Jun 30, 2025 to Dec 31, 2026 · 2 morev10 Show 5 more changesShow less
    • Primary completion date: Jul 30, 2023 to Dec 31, 2024
    • Study sites: 19 to 20
    • Completion date: Jun 30, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 119 words
    • Secondary endpoints: details revised at 2 of 14 entries

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 18 to 19v9
  4. Primary completion date: Oct 30, 2022 to Jul 30, 2023 Completion date: Sep 30, 2024 to Jun 30, 2025 · Site details revised at 1 of 18 sites · Study description expanded, about 2 wordsv8 Show 3 more changesShow less
    • Completion date: Sep 30, 2024 to Jun 30, 2025
    • Site details revised at 1 of 18 sites
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 15 to 18v7
  6. Study sites: 6 to 15 Primary completion date: May 30, 2022 to Oct 30, 2022 · Completion date: Apr 30, 2024 to Sep 30, 2024 · Eligibility criteria expanded, about 86 words · 1 morev6 Show 4 more changesShow less
    • Primary completion date: May 30, 2022 to Oct 30, 2022
    • Completion date: Apr 30, 2024 to Sep 30, 2024
    • Eligibility criteria expanded, about 86 words
    • Secondary endpoints: 9 to 14

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 3 to 6v5
  8. Study sites: 1 to 3v4
  9. Study title revisedv3 See this version in full on ClinicalTrials.gov ↗
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Apr 30, 2022 to May 30, 2022 · Completion date: Mar 30, 2024 to Apr 30, 2024 · 2 morev2 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Apr 30, 2022 to May 30, 2022
    • Completion date: Mar 30, 2024 to Apr 30, 2024
    • Start date changed from estimate of Mar 30, 2021 to May 25, 2021
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  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.
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.
Trial Details
NCT Number NCT04792489
Lead Sponsor Miltenyi Biomedicine GmbH
Conditions Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma, High Grade B-cell Lymphoma (HGBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), Transformed Lymphoma, Central Nervous System Lymphoma, Mantle Cell Lymphoma (MCL), Richter Transformation +1 more
Enrollment 315 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov