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NCT03853616
A Phase I Safety, Dose Finding and Feasibility Trial of MB-CART19.1 in Patients With Relapsed or Refractory CD19 Positive B Cell Malignancies
Phase 1 trial testing MB-CART19.1 in Acute Lymphoblastic Leukemia Recurrent in 48 participants. Participants enrolled and being followed up; not accepting new ones.
1 June 2026
Quick facts
| Lead sponsor | Miltenyi Biomedicine GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 26 November 2018 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 June 2026 |
| Sites | 9 locations across Germany |
Drugs / interventions tested
- MB-CART19.1 — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia Recurrent — all drugs for Acute Lymphoblastic Leukemia Recurrent →
- B-cell Lymphoma Recurrent — all drugs for B-cell Lymphoma Recurrent →
- B-cell Lymphoma Refractory — all drugs for B-cell Lymphoma Refractory →
- Chronic Lymphocytic Leukemia Recurrent — all drugs for Chronic Lymphocytic Leukemia Recurrent →
Sponsor
Miltenyi Biomedicine GmbH — full company profile →
Who can join
1 and older, any sex, with Acute Lymphoblastic Leukemia Recurrent or B-cell Lymphoma Recurrent. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Determination of the recommended dose of MB-CART19.1
Time frame: until day 28 after infusion of MB-CART19.1
Maximum tolerated dose (MTD), defined as the highest dose level of the two to three dose levels tested at which \<33% of patients experience DLT until day 28 after infusion of MB-CART19.1, on the basis of safety and toxicity assessment of MB-CART19.1 per adverse events (AE) reporting classified according to CTCAE version 5.0.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03853616
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MB-CART19.1
Trials testing the same drug.
- NCT06189157 — MB-CART19.1 in Refractory SLE · Phase 1, PHASE2 · recruiting
- NCT06508775 — Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies · NA · recruiting
- NCT03321123 — MB-CART19.1 in Patients With R/R ALL · Phase 2 · unknown
Other Miltenyi Biomedicine GmbH trials
Trials by the same sponsor.
- NCT06225050 — M-2018-334 in Hematological Malignancies · NA · not yet recruiting
- NCT07178431 — MB-CART2019.1 in Refractory Multiple Sclerosis · Phase 1, PHASE2 · not yet recruiting
- NCT07288879 — DALY II Japan/MB-CART2019.1 for DLBCL · Phase 2 · recruiting
- NCT06508931 — Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms · Phase 2 · recruiting
- NCT06189157 — MB-CART19.1 in Refractory SLE · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03853616 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Miltenyi Biomedicine GmbH
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03853616.
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