Clinical trial · Interventional
Safety Study of the Bispecific T-cell Engager Blinatumomab (MT103) in Patients With Relapsed NHL
An Open-label, Multi-center Phase I Study to Investigate the Tolerability and Safety of a Continuous Infusion of the Bispecific T-cell Engager MT103 in Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)
- 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)
The purpose of this study is to determine whether a continuous infusion of Blinatumomab (MT103) is safe in the treatment of relapsed Non-Hodgkin's Lymphoma. Furthermore, the study is intended to provide pharmacokinetic and pharmacodynamic data of Blinatumomab as well as to get first indication of tumour activity.
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma, Relapsed | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinatumomab (MT103) | Biological | Blinatumomab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blinatumomab
- description
- Patients received blinatumomab as continuous intravenous infusion for 4 weeks. Participants with clinical benefit were permitted to continue for another 4 weeks for a total of 8 weeks. Participants with a clinical benefit 4 weeks after completion of the first cycle of treatment could also receive additional treatment approximately 3 months ater the end of infusion at the same dose level.
- interventionNames
- Biological: Blinatumomab (MT103)
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- From the first infusion of blinatumomab until the safety follow-up visit 2 weeks after end of the treatment period, including the consolidation and relapse periods. The median treatment duration was 33.24 days.
- description
- Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients with first or later relapse of histologically (World Health Organisation classification) confirmed:
* follicular lymphoma (grade I/II)
* marginal zone lymphoma
* lymphoplasmocytic lymphoma
* mantle cell lymphoma
* diffuse large B-cell lymphoma
* small lymphocytic lymphoma requiring therapy and not eligible for curative treatment
2. Measurable disease (at least one lesion \>= 1.5 cm) documented by computed tomography (CT) scan
3. Age \>= 18 years
4. Eastern Cooperative Oncology Group (ECOG) performance status \<=2
5. Life expectancy of at least 6 months
6. Ability to understand the patient information and informed consent form
7. Signed and dated written informed consent is available
8. B:T cell ratio (Fluorescence-Activated Cell Sorter \[FACS\] analysis results by central lab) available before study entry.
Exclusion Criteria:
1. Any other NHL not listed in inclusion criterion 1
2. Abnormal laboratory values as defined below:
* Peripheral lymphocyte count \> 20 x 10\^9/L
* Platelet counts ≤ 75,000/µL
* Hemoglobin level ≤ 9 g/dL
* Venous pH value out of normal range or oxygen saturation ≤ 90%
3. Known or suspected central nervous system (CNS) involvement by NHL
4. a)History of or current relevant CNS pathology as epilepsy, seizure, paresis,aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis b)Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI
5. Autologous stem cell transplantation within 12 weeks prior to study entry
6. Allogeneic stem cell transplantation
7. Cancer chemotherapy within 4 weeks prior to study entry
8. Radiotherapy within 4 weeks prior to study entry
9. Treatment with rituximab within 4 weeks prior to study entry
10. Prior treatment with alemtuzumab 12 weeks prior to study entry
11. Treatment with any investigational agent within 12 weeks prior to study entry
12. Contraindication for any of the concomitant medications
13. Abnormal renal or hepatic function as defined below:
* Aspartate aminotransferase (AST; SGOT) and/or alanine aminotransferase (ALT; SGPT) \>= 2 x upper limit of normal (ULN)
* total bilirubin \>= 1.5 x ULN
* serum creatinine \>= 2 x ULN
* creatinine clearance \< 50mL/min
14. Indication of hypercoagulative state as defined below:
-antithrombin activity \<LLN
15. Presence of human anti-murine antibodies (HAMA) or known hypersensitivity to immunoglobulins
16. History of malignancy other than B-cell lymphoma within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix
17. Active infection / not yet recovered from recent infection; known bacteriemia
18. Any concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
19. Regular dose of corticosteroids during the four weeks prior to D1 of this study or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent, or any other immunosuppressive therapy within 4 weeks prior to study entry
20. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B or hepatitis C virus
21. Pregnant or nursing women, or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Male patients not willing to ensure that during the study and at least three months thereafter no fathering takes place.References
Publications (2)
- DERIVEDNagele V, Zugmaier G, Goebeler ME, Viardot A, Bargou R, Kufer P, Klinger M. Relationship of T- and B-cell kinetics to clinical response in patients with relapsed/refractory non-Hodgkin lymphoma treated with blinatumomab. Exp Hematol. 2021 Aug;100:32-36. doi: 10.1016/j.exphem.2021.06.005. Epub 2021 Jul 3. PMID 34228983
- DERIVEDZhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE((R))) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4. PMID 27209293