Clinical trial · Interventional
A Clinical Study Using MEDI-551 in Adult Participants 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 Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies
NCT00983619CI-TRIAL-00045083completedPhase 1 / Phase 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)
The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in participants with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).
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 |
|---|---|---|---|
| B-cell Malignancies | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI-551 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- Part A-MEDI-551 0.5 mg/kg
- description
- Participants will receive intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.
- interventionNames
- Drug: MEDI-551
- type
- EXPERIMENTAL
- label
- Part A-MEDI-551 1 mg/kg
- description
- Participants will receive IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.
- interventionNames
- Drug: MEDI-551
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed CLL, DLBCL, FL, or MM; * Karnofsky Performance Status \>= 70; * Life expectancy of \>= 12 weeks; * Prior radiation therapy provided exposure does not exceed an area of 25% of marrow space * Adequate hematological function * Adequate organ function Exclusion Criteria: * Any available standard line of therapy known to be life-prolonging or life-saving; * No concurrent therapy or therapy within six weeks of first dose of MEDI-551 for treatment of cancer * Previous therapy directed against CD19 * Vaccination (other than experimental cancer vaccine therapy) within 28 days prior to receiving the first dose of MEDI-551; * History of other invasive malignancy within 5 years except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured; * Active infection requiring treatment * Autologous stem cell transplantation within 4 months prior to study entry; * Allogeneic stem cell transplantation or any other organ transplant; * Ongoing \>= Grade 2 toxicities from previous cancer therapies unless specifically allowed in the Inclusion/Exclusion criteria. * Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551; * Use of immunosuppressive medication other than steroids within 28 days before the first dose of MEDI-551 (inhaled and topical corticosteroids are permitted); * Documented current central nervous system involvement by leukemia or lymphoma; * Pregnancy or lactation; * Clinically significant abnormality on ECG.
References
Publications (0)
Data not yet available
No reference posted for this study.