Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
milatuzumab · 4 trials · 10 indications
Dose-limiting toxicity was assessed during induction therapy for phase I.
Patients received a fixed dose of Veltuzumab IV 200 mg/m2 and Milatuzumab was dose escalated
Per International Response Criteria (Cheson JCO 2007) for target lesions and assessed by CT, MRI or PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; Overall Response (OR) = CR + PR.
Will be assessed using laboratory and clinical data comparing baseline lab results and clinical condition to the lab results and clinical condition/adverse events during treatment and follow-up timepoints up to 2 years.
Will be assessed using the BILAG scoring model for lupus disease activity and symptoms by comparing baseline BILAG measurements against the BILAG measurements obtained during treatment and during follow-up for up to 2 years.
| Arm | Type | Description |
|---|---|---|
| Phase I | EXPERIMENTAL | Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. |
| Phase II | EXPERIMENTAL | Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. |
| milatuzumab | EXPERIMENTAL | different doses of hLL1 |
| Multiple Doses | OTHER | Multiple Dose levels |
| Milatuzumab SC 250 mg | EXPERIMENTAL | Milatuzumab 250 mg will be administered subcutaneously once weekly for 4 weeks. |
| Milatuzumab 150 mg SC | EXPERIMENTAL | Milatuzumab 150 mg will be administered subcutaneously once weekly for 4 weeks. |
| Placebo SC | PLACEBO_COMPARATOR | Placebo will be administered subcutaneously once weekly for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| milatuzumab | BIOLOGICAL | Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36. |
| veltuzumab | BIOLOGICAL | Patient will receive veltuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36. |
| Correlative/Special Studies | PROCEDURE | To correlate Fcγ receptor polymorphisms with response to treatment with the combination of veltuzumab and milatuzumab. Whole blood will be collected pre-treatment on day 1. |
| Quantitative T-, B-, and NK cell subsets | PROCEDURE | Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 pre-treatment on day 1, after induction (week 5, day 1), and prior to the start of therapy on day 1 week 12, day 1 week 36, and then every 4 months for one year. |
| Pharmacokinetics | PROCEDURE | To assess the pharmacokinetics of veltuzumab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Pharmacokinetics will be assessed with blood samples collected at the following time points: immediately pre- and post-infusion on day 1 of weeks 1, 2, 4, 12 and 36. One additional sample will be collected each of weeks 5 through 10 (sample may be collected any day during each of these weeks). |
| Human Anti-Human Antibodies | PROCEDURE | To monitor for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA) in patients receiving treatment with veltuzumab and milatuzumab. Patients will be monitored for the development of HAHA at the following timepoints: pre-treatment on day 1 of week 1, pre-treatment on day 1 of week 4, pre-treatment on day 1 of week 12, and pre-treatment on day 1 of week 36. |
| veltuzumab and milatuzumab | BIOLOGICAL | Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks 12, 20, 28, and 36. |
| Placebo | DRUG | Placebo will be administered subcutaneously once weekly for 4 weeks. |
Inclusion Criteria: * Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including any of the following: * Marginal zone lymphoma * Waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma) * Follicular lymphoma * Mantle cell lymphoma * Relapsed or refractory disease after ≥ 1 pr...
Milatuzumab is an investigational monoclonal antibody being studied for use in lupus erythematosus, cutaneous, multiple myeloma, lymphoma, and chronic lymphocytic lymphoma. It is in Phase 1 clinical development and is not yet approved by the FDA.
Milatuzumab is being developed by Gilead Sciences, Inc., which trades on the NASDAQ under the ticker GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology and autoimmune indications.
Milatuzumab is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials have been completed for multiple myeloma, chronic lymphocytic lymphoma, lymphoma, and lupus erythematosus, cutaneous.
Milatuzumab has been studied in several completed Phase 1 trials, including NCT00421525 for multiple myeloma, NCT00603668 for chronic lymphocytic lymphoma, NCT00989586 for lymphoma, and NCT01845740 for lupus erythematosus, cutaneous. These trials were conducted in the United States.
Milatuzumab is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. It is being investigated for its potential effects in oncology and autoimmune conditions, though the exact mechanism of action is not specified.