Clinical trial · Interventional
Study of MDX-1411 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
A Phase I, Open-Label, Multicenter, Dose-escalation, Multidose Study of MDX-1411 Administered Every 7 Days in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma
NCT00730652CI-TRIAL-00003381MDX1411-02withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
To determine if MDX-1411 is safe for the treatment of chronic lymphocytic leukemia or mantle cell lymphoma.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma. | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDX-1411 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MDX1411
- description
- An accelerated titration design (ATD) will be utilized and subjects will be assigned to a dose level in the order they enter the study.
- interventionNames
- Biological: MDX-1411
Primary outcomes (1)
- measure
- Safety Profile of MDX-1411 and determine the maximum tolerated dose (MTD)
- timeFrame
- Day 1-40
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of relapsed/refractory MCL or hematologically/bone marrow confirmed relapsed/refractory CLL that is not amenable to cure by surgery or other means and has failed at least 1 prior systemic therapy; * Subjects may have been treated with up to 6 prior systemic therapies for relapsed/refractory disease or have become intolerant to a systemic therapy * For MCL, must have measurable disease * At least 4 weeks since the last systemic therapy, including RT, for the treatment of MCL/CLL; * At least 4 weeks since taking any corticosteroids prior to the first dose of MDX-1411 * ECOG Performance Status 0 to 2; * No known positivity for human immunodeficiency virus (HIV) and no active infection with Hepatitis B or Hepatitis C; Exclusion Criteria: * History of severe hypersensitivity reactions to other monoclonal antibodies; * Use of other investigational drugs within 30 days before study drug administration * Prior treatment with any other anti-CD70 antibody; * Active infection requiring i.v. systemic therapy within 4 weeks of receiving the first dose of MDX-1411; * Evidence of bleeding diathesis or coagulopathy; * Active autoimmune disease requiring immunosuppressive therapy; * Known current drug or alcohol abuse; * Underlying medical conditions that will make the administration of MDX-1411 hazardous
References
Publications (0)
Data not yet available
No reference posted for this study.