Clinical trial · Interventional
Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM
A Phase I/II Open Label Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of ALXN6000 In Patients With Relapsing Or Refractory B-Cell Chronic Lymphocytic Leukemia Or Multiple Myeloma
NCT00648739CI-TRIAL-00037454terminatedPhase 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
Why stopped (as posted): The study was terminated by the Sponsor for administrative reasons and not due to any safety concerns.
Summary
Brief summary (as posted)
The purpose of this study was to determine the safety and maximum tolerated dose (MTD) of ALXN6000 (samalizumab) in treating relapsing or refractory B-cell chronic lymphocytic leukemia (B-CLL) or multiple myeloma (MM) and to study how samalizumab may help the immune system fight tumors that express CD200.
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 Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Samalizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Samalizumab
- description
- All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose. If no participants enrolled into a cohort experienced a DLT, escalation to the next dose level occurred with a new cohort. If any 1 of the initial 3 participants in the cohort experienced a DLT, the cohort was expanded to at least 6 participants. Then, if less than one third of participants within the cohort experienced a DLT, escalation to the next dose level occurred with a new cohort. Dose cohorts were enrolled sequentially.
- interventionNames
- Drug: Samalizumab
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) Of Samalizumab
- timeFrame
- From first dose through 10 weeks after the last dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Relapsing or Refractory B-CLL or MM * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Anticipated survival of greater than 6 months * Female participants of childbearing potential must agree to use 2 forms of contraception * Participants must have a standard indication for treatment of their malignancy * Is willing and able to give written informed consent prior to any procedure not considered standard of care Exclusion Criteria: * Absolute neutrophil count (ANC) \< 1000 x 10\^9/liter (L) * Platelet count \< 50,000 x 10\^9/L * Pregnant or lactating women * Prior history of autoimmune hemolysis requiring therapy * Prior history of immune thrombocytopenia * Active autoimmune disease requiring immunosuppressive therapy * Positive Coombs' Test (neither direct or indirect) * Ongoing corticosteroid treatment equivalent to the mineralocorticoid potency of 10 milligrams (mg) /day of prednisone, or greater, for any condition * Prior stem cell transplantation within 4 weeks prior to enrollment * Prior chemotherapy for the applicable malignancy within 30 days of enrollment * Neurosurgery or cranial radiation therapy within 1 year of enrollment * Clinically significant renal, hepatic, or cardiopulmonary disease
References
Publications (1)
- DERIVEDMahadevan D, Lanasa MC, Farber C, Pandey M, Whelden M, Faas SJ, Ulery T, Kukreja A, Li L, Bedrosian CL, Zhang X, Heffner LT. Phase I study of samalizumab in chronic lymphocytic leukemia and multiple myeloma: blockade of the immune checkpoint CD200. J Immunother Cancer. 2019 Aug 23;7(1):227. doi: 10.1186/s40425-019-0710-1. PMID 31443741