Clinical Trial

Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia

Study acronym: Anti-CD19-ALL
Recruiting Phase 1/2
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Summary
The objective of the trial is to evaluate the safety, clinical toxicity and in vivo immunological effects of MOR00208 in pediatric patients with acute lymphoblastic leukemia who showed newly emerging or persistent MRD after a first stem cell transplantation, received stem cell transplantation without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT or underwent a second or subsequent stem cell transplantation irrespective of MRD after SCT. Part I: to determine the recommended dose of MOR00208 in pediatric patients Part II: to evaluate the time until hematological relapse or increase of MRD
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-05-04; most recent amendment 2026-02-02.
Status change: Not Yet Recruiting → Recruiting 2023-03-08
Trial Details
NCT Number NCT05366218
Lead Sponsor University Hospital Tuebingen
Conditions ALL, Childhood B-Cell, Acute Lymphoid Leukemia Relapse, Acute Lymphocytic Leukemia Refractory
Enrollment 20 participants
Start Date 2023-03-08
Primary Completion 2028-07 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-02-05