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MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later across 2 updates Jun 2026 → Nov 2026
See other at-risk trials from Miltenyi Biomedicine GmbH

Record History

  1. Primary and study completion pushed from Sep 2026 to Nov 2026 Eligibility criteria expanded, about 36 words · Secondary endpoints: details revised at 3 of 11 entries · Site details revised at 3 of 9 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 3 of 11 entries
    • Site details revised at 3 of 9 sites
  2. Primary and study completion pushed from Jun 2026 to Sep 2026v12
  3. Primary and study completion dates: Mar 2026 to Jun 2026v11
  4. Phase: Phase 1/2 to Phase 1 Primary endpoints: 2 to 1 · Secondary endpoints: 13 to 11 · Study description shortened, about 89 words · 1 morev10 Show 4 more changesShow less
    • Primary endpoints: 2 to 1
    • Secondary endpoints: 13 to 11
    • Study description shortened, about 89 words
    • Study arms: 5 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Recruiting to Active, Not Recruiting Study sites: 11 to 9v9 Show 1 more changeShow less
    • Study sites: 11 to 9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Primary and study completion dates: Dec 2024 to Mar 2026v7
  3. Study sites: 10 to 11v6
  4. Primary completion date: Dec 2023 to Dec 2024 Site contacts updated at 1 of 10 sitesv5 Show 1 more changeShow less
    • Site contacts updated at 1 of 10 sites
  5. Primary completion date: Aug 2022 to Dec 2023 Completion date: Dec 2022 to Dec 2024v4 Show 1 more changeShow less
    • Completion date: Dec 2022 to Dec 2024
  6. Primary completion date: Jul 2021 to Aug 2022 Study sites: 3 to 10 · Completion date: Jul 2022 to Dec 2022v3 Show 2 more changesShow less
    • Study sites: 3 to 10
    • Completion date: Jul 2022 to Dec 2022
  7. Primary completion date: Jul 2020 to Jul 2021 Completion date: Jul 2020 to Jul 2022 · Eligibility criteria shortened, about 6 wordsv2 Show 2 more changesShow less
    • Completion date: Jul 2020 to Jul 2022
    • Eligibility criteria shortened, about 6 words

    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.
Miltenyi Biomedicine GmbH
15 trials monitored
See 3 trials at risk
Leukemia
2,566 trials monitored
See 143 trials at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
Acute Lymphoblastic Leukemia (ALL)
885 trials monitored
See 51 trials at risk
and 1 more disease
This is a phase l multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. In total approximately 48 patients will be included in the trial. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).
Trial Details
NCT Number NCT03853616
Lead Sponsor Miltenyi Biomedicine GmbH
Conditions Acute Lymphoblastic Leukemia Recurrent, B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory, Chronic Lymphocytic Leukemia Recurrent, Chronic Lymphocytic Leukemia Refractory
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov