Clinical trial · Interventional
A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
NCT01957579CI-TRIAL-00028079completedPhase 1Results 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)
The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced B Cell Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Blood Cancer | Liquid Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI-551 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEDI-551
- interventionNames
- Drug: MEDI-551
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- From baseline to 30 days after the last dose of study drug
Secondary outcomes (15)
- measure
- Number of Participants With Dose Limiting Toxicities
- timeFrame
- From baseline to 28 days after the first dose of study drug
- description
- A MEDI-551 treatment-related AE of any toxicity grade that lead to an inability to receive a full cycle (2 doses) of MEDI-551, or, any Grade 3 or higher toxicity that could not be reasonably ascribed to another cause, such as disease progression or accident.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: * Japanese men or women at least 20 years of age * Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL, or MM. * Karnofsky Performance Status ≥70; * Life expectancy of ≥12 weeks Exclusion Criteria: * Any available standard line of therapy known to be life-prolonging or life-saving * Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer * Previous therapy directed against CD19, such as monoclonal antibodies or MAb conjugates
References
Publications (0)
Data not yet available
No reference posted for this study.