ALL, Childhood B-CellPhase 1/2Anti-CD19-ALLNCT05366218
Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia
A Phase 1/2 study testing Tafasitamab in people with ALL, Childhood B-Cell and Acute Lymphoid Leukemia Relapse, run by University Hospital Tuebingen at 11 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- ALL, Childhood B-Cell, Acute Lymphoid Leukemia Relapse, Acute Lymphocytic Leukemia Refractory
- What is being tested?
- Tafasitamab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 11 sitesGermany
- Study dates
- 8 Mar 2023to Feb 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 18Show fewer
- 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.
- Males must agree
- to use a latex condom during any sexual contact with FCBP while participating in the study and for 3 months following discontinuation from this study, even if he has undergone a successful vasectomy
- to refrain from donating semen or sperm during study participation and for 3 months after discontinuation from this study treatment.
Who cannot join
- 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
Show all 16Show fewer
- 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
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Germany11 sites, 11 recruiting
- Recruiting
Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, 13353
Sandra Cyrull, Dr.
Arend von Stackelberg, Dr.
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Roland Meisel, Prof. Dr.
Sujal Ghosh, Dr.
- Not yet recruiting
Universitätsklinikum
Essen, 45147
Stefan Schönberger, Dr.
Michaela Höfs, Dr.
- Not yet recruiting
Universitätsklinikum, Klinik für Kinder- und Jugendmedizin
Frankfurt, 60590
Peter Bader, Prof.
Andrea Jarisch, Dr.
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Brigitte Strahm, Dr.
Carsten Speckmann, Dr.
- Recruiting
Zentrum für Geburtshilfe, Kinder- und Jugendmedizin
Hamburg, Free and Hanseatic City of Hamburg, 20246
Ingo Müller, Prof. Dr.
Manon Quedeville, Dr.
- Recruiting
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Gunnar Cario, Prof.
Vieth Simon, Prof.
- Not yet recruiting
Klinikum Dr. von Haunersches Kinderspital
München, Bavaria, 80337
Tobias Feuchtinger, Prof. Dr.
Semjon Willer, Dr.
- Recruiting
University childrens Hospital
Tübingen, Baden-Wurttemberg, 72076
Peter Lang, Prof. Dr., 004970712984744, peter.lang@med.uni-tuebingen.de
Michael Abele, Dr., 0049707184744, michael.abele@med.uni-tuebingen.de
- Recruiting
Klinik für Kinder- und Jugendmedizin
Ulm, Baden-Wurttemberg, 89070
Ansgar Schulz, Prof. Dr.
Manfred Hönig, Prof. Dr.
- Recruiting
Universitäts-Kinderklinik
Würzburg, 97080
Matthias Eyrich, Prof.
Paul-Gerhardt Schlegel, Prof.
About this study
Official title: A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia
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
Read the detailed description
Acute lymphoblastic leukemia is the most common malignancy in children. In patients with > 2nd relapse or in patients who relapse after previous stem cell transplantation (SCT), conventional chemotherapy or even subsequent SCT results only in low probabilities for event free survival (1-year EFS ~30%) with a generally poor prognosis. Major cause of death is a subsequent relapse. To date there is no standard therapy available. The aim of this study is to establish an antibody approach as an additional therapy. Therefore, the safety and efficacy of the anti-CD19-antibody tafasitamab in such pediatric very high-risk patients will be evaluated. Patients will be included in the following stages of disease: newly emerging or persistent minimal residual disease (MRD) after a first SCT; SCT without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT; underwent a second or subsequent SCT irrespective of MRD after SCT. Tafasitamab will be used as a relapse prophylaxis as well as a treatment for patients with low detectable low MRD. The treatment is intended to reduce the likelihood of overt relapse after SCT in a collective of patients at highest risk of relapse, thereby improving the long-term survival of these patients. The bi-weekly application of anti-CD19-antibody has already shown promising results in compassionate use settings in pediatric patients. Furthermore, the safety of tafasitamab has already been analyzed in multiple studies in adults and has proven to be well tolerable. As a control group published data for these patient groups will be used with a combined 1-year EFS of 30% in which patients have been treated at the current standard of care.
The study consists of 2 parts:
The first part will evaluate safety along with the maximum tolerated dose of tafasitamab in pediatric patients. This will involve intra- and inter-individual dose escalation using pre-determined dose levels before the dose-finding phase is completed. If dose-limiting drug side effects occur during this dose-finding phase, additional patients will be included in the interindividual dose escalation until the maximum tolerated dose of tafasitamab is defined for the remainder of the study. For this dose-finding phase, a minimum of six and a maximum of 25 patients will be included.
Immediately thereafter, the second study phase begins, in which all patients from the dose-finding phase who have not experienced a dose-limiting toxicity, as well as additional enrolled patients, receive the defined maximum tolerated dose of tafasitamab. In this phase of the study, in addition to the continued recording of drug side effects, the efficacy of tafasitamab will be assessed using defined endpoints. A minimum evaluable number of 18 patients is planned for the assessment of these endpoints; to compensate for possible patient dropout during the study, recruitment of a minimum of 20 patients and a maximum of 39 patients, depending on the course of the dose-finding phase, is planned.
- Conditions
- ALL, Childhood B-Cell, Acute Lymphoid Leukemia Relapse, Acute Lymphocytic Leukemia Refractory
- Being tested
- Tafasitamab
- Keywords
- CD19 positive, refractory to standard treatment, relapse
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafasitamabBiological
Also called MOR00208
Antibody vaccination
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Tafasitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint Part I
Determination of maximum tolerated dose of MOR00208 in pediatric patients
Measured: 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
Measured: 545 days
Secondary outcomes (8)
Pharmakokinetic of MOR00208
Mean plasma concentrations of MOR00208 will be calculated and displayed graphically
Measured: 8 days
Safety and toxicity of MOR00208 - Part I
Adverse events will be presented in line listings and also in cumulative tabulations
Measured: 49 days
Treatment success
Rate of patients with treatment success defined as survival without newly emerging MRD or increasing MRD ≥ 2 log in bone marrow or peripheral blood or unacceptable toxicity
Measured: 365 days
Overall survival
OS from date of first dose until end of follow up at 545 days will be analyzed using Kaplan-Meier-Methods, presenting corresponding statistical parameters and 95% confidence limits and Kaplan-Meier survival curves. Patients alive at 545 days and patients that could not be followed up until 545 days but were seen alive at the last visit will be censored.
Measured: 545 days
MRD reduction
The amount of patients with reduction of at least 1 log at any time point compared to baseline MRD measurement between SCT and start of study treatment will be calculated and displayed graphically. Rates and 95%-confidence limits are also provided.
Measured: 545 days
B cell numbers
Mean B cell numbers will be calculated and displayed graphically with 95%-confidence limits.
Measured: 545 days
Cytotoxic lysis
Cytotoxic lysis will be calculated and displayed graphically.
Measured: 545 days
Safety and toxicity of MOR00208 - Part II
Adverse events will be presented in line listings and also in cumulative tabulations
Measured: 545 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start8 Mar 2023
- Primary completionJul 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL, Childhood B-CellStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lang, Prof., Principal investigator, University Childrens Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366218
- Sponsor's protocol ID
- 2022-000557-88
- Other IDs
- 2024-511336-28-00
- Acronym
- Anti-CD19-ALL
- Status last verified
- Feb 2026
- First submitted
- 4 May 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia
- ClinicalTrials.gov ID
- NCT05366218
- Acronym / sponsor ID
- Anti-CD19-ALL / 2022-000557-88
- Conditions
- ALL, Childhood B-Cell, Acute Lymphoid Leukemia Relapse, Acute Lymphocytic Leukemia Refractory
- Keywords
- CD19 positive, refractory to standard treatment, relapse
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Acute lymphoblastic leukemia is the most common malignancy in children. In patients with > 2nd relapse or in patients who relapse after previous stem cell transplantation (SCT), conventional chemotherapy or even subsequent SCT results only in low probabilities for event free survival (1-year EFS ~30%) with a generally poor prognosis. Major cause of death is a subsequent relapse. To date there is no standard therapy available. The aim of this study is to establish an antibody approach as an additional therapy. Therefore, the safety and efficacy of the anti-CD19-antibody tafasitamab in such pediatric very high-risk patients will be evaluated. Patients will be included in the following stages of disease: newly emerging or persistent minimal residual disease (MRD) after a first SCT; SCT without having reached a sufficient molecular remission prior to transplant (defined as MRD ≥10E-4) irrespective of MRD after SCT; underwent a second or subsequent SCT irrespective of MRD after SCT. Tafasitamab will be used as a relapse prophylaxis as well as a treatment for patients with low detectable low MRD. The treatment is intended to reduce the likelihood of overt relapse after SCT in a collective of patients at highest risk of relapse, thereby improving the long-term survival of these patients. The bi-weekly application of anti-CD19-antibody has already shown promising results in compassionate use settings in pediatric patients. Furthermore, the safety of tafasitamab has already been analyzed in multiple studies in adults and has proven to be well tolerable. As a control group published data for these patient groups will be used with a combined 1-year EFS of 30% in which patients have been treated at the current standard of care.
The study consists of 2 parts:
The first part will evaluate safety along with the maximum tolerated dose of tafasitamab in pediatric patients. This will involve intra- and inter-individual dose escalation using pre-determined dose levels before the dose-finding phase is completed. If dose-limiting drug side effects occur during this dose-finding phase, additional patients will be included in the interindividual dose escalation until the maximum tolerated dose of tafasitamab is defined for the remainder of the study. For this dose-finding phase, a minimum of six and a maximum of 25 patients will be included.
Immediately thereafter, the second study phase begins, in which all patients from the dose-finding phase who have not experienced a dose-limiting toxicity, as well as additional enrolled patients, receive the defined maximum tolerated dose of tafasitamab. In this phase of the study, in addition to the continued recording of drug side effects, the efficacy of tafasitamab will be assessed using defined endpoints. A minimum evaluable number of 18 patients is planned for the assessment of these endpoints; to compensate for possible patient dropout during the study, recruitment of a minimum of 20 patients and a maximum of 39 patients, depending on the course of the dose-finding phase, is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Prospective Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy
| Arm | Type | Receives |
|---|---|---|
| Tafasitamab | Experimental | Biological: TafasitamabAll 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- 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
- Females of childbearing potential (FCBP1) must agree
- Males must agree
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TafasitamabAlso: MOR00208Antibody vaccination | Biological | Tafasitamab |
Primary outcome
Primary endpoint Part I
Time frame: 49 days
Determination of maximum tolerated dose of MOR00208 in pediatric patients
Primary endpoint Part II
Time frame: 545 days
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
8 secondary outcomes
Pharmakokinetic of MOR00208
Time frame: 8 days
Safety and toxicity of MOR00208 - Part I
Time frame: 49 days
Treatment success
Time frame: 365 days
Overall survival
Time frame: 545 days
MRD reduction
Time frame: 545 days
B cell numbers
Time frame: 545 days
Cytotoxic lysis
Time frame: 545 days
Safety and toxicity of MOR00208 - Part II
Time frame: 545 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Lang, Prof. principal investigator
University Childrens Hospital Tübingen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tafasitamab in people with ALL, Childhood B-Cell and Acute Lymphoid Leukemia Relapse, run by University Hospital Tuebingen at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Lang, Prof. (0049 7071 2984744, peter.lang@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint Part I (time frame: 49 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.