Clinical trial · Interventional
Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)
A Phase IIa, Single-arm, Open-label Study of MOR00208, a Humanized Fc-Engineered Anti-CD19 Antibody, in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)
NCT01685021CI-TRIAL-00031746terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MOR00208 (formerly Xmab5574) | Drug | Tafasitamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MOR00208 (formerly Xmab5574)
- description
- intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
- interventionNames
- Drug: MOR00208 (formerly Xmab5574)
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Throughout during study until progression, after each treatment cycle
- description
- ORR= CR (Complete Remission) + PR (Partial Remission) Antitumor activity of MOR00208
Secondary outcomes (5)
- measure
- Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT
- timeFrame
- Throughout during study until progression, after each treatment cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with previously treated Philadelphia-chromosome-negative B-ALL, with progression after at least one prior therapy. Patients with Philadelphia-chromosome-positive B-ALL can only be included if they are refractory or intolerant to at least one tyrosine-kinase-inhibitor. * Male or female patients at least 16 years of age; if the patient is less than 18 years of age, the patient must have the ability to understand and give written assent in addition to the parent's/guardian's written informed consent. * Patients with histologically confirmed diagnosis of B-ALL * Mixed phenotype acute leukemia patients who have B cell immunophenotype. * Patients with an Eastern Cooperative Oncology Group performance status of less than or equal to 2 * Patients with a total bilirubin of less than or equal to 2.0 mg/dL * Patients with alanine aminotransferase or aspartate aminotransferase less than or equal to 2.5 times the upper limit of normal * Patients with a creatinine level of less than or equal to 2.0 mg/dL * If a female of childbearing potential, confirmation of a negative pregnancy test before enrollment and use of double-barrier contraception, confirmation of a negative pregnancy test before enrollment and use of oral contraceptive plus barrier contraceptive, or confirmation of having undergone clinically documented total hysterectomy, oophorectomy, or tubal ligation * If a male, use of an effective barrier method of contraception during the study and for 3 months after the last dose if sexually active with a female of childbearing potential * Patients with the ability to understand and give written informed consent and to comply with the study protocol Exclusion Criteria: * Patients who received previous treatment with an anti-CD19 antibody or fragments * Receipt of anti-CD20 therapy no greater than 4 weeks before the first study dose * Patients having undergone prior allogeneic stem cell transplantation within 3 months or having active graft versus host disease * Patients with known hypersensitivity to any excipient contained in the drug formulation * Patients with a New York Heart Association Class III or IV * History of stroke or myocardial infarction within the last 6 months * Patients with a history of positive human immunodeficiency virus test result (ELISA or western blot) * Patients with positive hepatitis serology. Hepatitis B (HBV): Patients with positive serology for hepatitis B, defined as positive for hepatitis B surface antigen (HbsAg) or total anti-hepatitis B core antibody (anti-Hbc). Patients positive for anti- Hbc may be included if hepatitis B viral DNA is not detectable. Hepatitis C (HCV): Patients with positive hepatitis C serology (defined as positive for anti-hepatitis C virus antibody (anti-HCV) unless HCV-RNA is confirmed negative. * Patients with active viral, bacterial, or systemic fungal infection requiring active parenteral treatment * Patients who are receiving active treatment/chemotherapy for another primary malignancy or have received any treatment, including surgery, radiation, or chemotherapy, within the past 5 years (except ductal breast cancer in situ, for nonmelanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) * Patients who are pregnant or breastfeeding * Patients with major surgery or radiation therapy within 4 weeks prior to first study dose
References
Publications (1)
- DERIVEDKlisovic RB, Leung WH, Brugger W, Dirnberger-Hertweck M, Winderlich M, Ambarkhane SV, Jabbour EJ. A phase 2a, single-arm, open-label study of tafasitamab, a humanized, Fc-modified, anti-CD19 antibody, in patients with relapsed/refractory B-precursor cell acute lymphoblastic leukemia. Cancer. 2021 Nov 15;127(22):4190-4197. doi: 10.1002/cncr.33796. Epub 2021 Aug 3. PMID 34343354