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

NCT05366218 | Recruiting Phase 1 DMC

• 2 other identifiers: 2022-000557-882024-511336-28-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 11

Brief 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

Conditions

ALL, Childhood B-Cell; Acute Lymphoid Leukemia Relapse; Acute Lymphocytic Leukemia Refractory

Keywords

CD19 positive; refractory to standard treatment; relapse

Outcome Measures

Primary Outcomes (2)

• Primary endpoint Part I

  Determination of maximum tolerated dose of MOR00208 in pediatric patients

  49 days

• Primary endpoint Part II

  Time until hematological relapse (\> 5% leukemic blasts) or increase of MRD ≥ 2 log in bone marrow during an observation time of 545 days accounting for competing risks

  545 days

Secondary Outcomes (8)

• Pharmakokinetic of MOR00208

  8 days

• Safety and toxicity of MOR00208 - Part I

  49 days

• Treatment success

  365 days

• Overall survival

  545 days

• MRD reduction

  545 days

Study Arms (1)

Tafasitamab

EXPERIMENTAL

All patients will receive MOR00208 over 2-3 hours i.v. MOR00208 will be administered on a bi-weekly (every fourteen days) basis with infusions on Days 1 and 15 of each 28-day cycle. Additional doses will be administered on Day 4, Day 8 and Day 22 of Cycle 1 as well as Day 8 and Day 22 of Cycle 2 and Cycle 3.

Biological: Tafasitamab

Interventions

Tafasitamab BIOLOGICAL

Antibody vaccination

Also known as: MOR00208

Tafasitamab

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≥ 3 years and \< 18 years at enrollment
• B-lineage (CD19 positive) ALL (B, pro-B, pre-B or c-ALL)
• Patients must have either
• underwent a first allogeneic stem cell transplantation after relapse with one of the following very high-risk somatic molecular alterations:
• KMT2A::AFF1 \[t(4;11) rearrangement
• TP53 alteration (mutation/deletion)
• low hypodiploidy (\<40 chromosomes, evident or masked)
• TCF3-PBX1 \[t(1;19)\]
• TCF3::HLF \[t(17;19)\] and irrespective of MRD after SCT or
• underwent a first allogeneic stem cell transplantation or a CAR T-cell therapy with newly emerging or persistent MRD load posttransplant / post CAR T- cell-treatment or
• have 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 allogeneic stem cell transplantation irrespective of MRD after SCT
• Females of childbearing potential (FCBP1) must agree
• to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 3 months before starting study drug, while participating in the study (including dose interruptions), and for at least 3 months after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe
• to abstain from breastfeeding during study participation and 3 months after study drug discontinuation.

You may not qualify if:

• Frank relapse (\>5% leukemic blasts)
• Philadelphia chromosome-positive (Ph+) ALL
• Ejection fraction \<25% on echocardiography
• Cystatin C-clearance \<40ml/min
• Liver function abnormalities with bilirubin \>4 mg/dL and elevation of transaminases higher than 400 U/L
• Severe infection (HIV, Chronic active viral hepatitis), tests have to be conducted at screening
• Acute GvHD III-IV or extensive chronic GvHD
• The following immunosuppressive drugs (≥ 1 week of administration):
• steroids ≥ 1mg/kg body weight, cytostatics (except intrathecal/ intracerebroventricular application for CNS treatment)
• Application of other experimental therapy modalities in the last 4 weeks
• Significant psychiatric disabilities, uncontrolled seizure disorders or severe peripheral neuropathy/ leukoencephalopathy
• Signs of autoimmune disease (i.e. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia)
• Subjects that do not agree to refrain from donating blood while on study drug
• Concurrent severe or uncontrolled medical disease which by assessment of the treating physician could compromise participation in the study
• Women during pregnancy and lactation

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (11)

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

University childrens Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Klinik für Kinder- und Jugendmedizin

Ulm, Baden-Wurttemberg, 89070, Germany

RECRUITING

Klinikum Dr. von Haunersches Kinderspital

München, Bavaria, 80337, Germany

NOT YET RECRUITING

Zentrum für Geburtshilfe, Kinder- und Jugendmedizin

Hamburg, Hamburg, 20246, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

RECRUITING

Universitätsklinikum

Essen, 45147, Germany

NOT YET RECRUITING

Universitätsklinikum, Klinik für Kinder- und Jugendmedizin

Frankfurt, 60590, Germany

NOT YET RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

RECRUITING

Universitäts-Kinderklinik

Würzburg, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

tafasitamab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Lang, Prof.

  University Childrens Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lang, Prof.

CONTACT

0049 7071 2984744; peter.lang@med.uni-tuebingen.de

Michael Abele, Dr.

CONTACT

0049 7071 2984744; michael.abele@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: March 8, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11)