Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4 · 1 trial · 1 indication
The MTD of a single application of Ch mAb 11-1F4 is defined as the highest safely-tolerated dose (mg/m2) where 0 patients experiences Dose Limiting Toxicity.
| Arm | Type | Description |
|---|---|---|
| Phase Ia | EXPERIMENTAL | Administration of Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4: A 1-patient cohort will be infused with 0.5 mg/m2 of Ch 11-1F4 and, if tolerated, the doses in the next patients will be increased to 5, 10, 50, 100, 250, and finally, 500 mg/m2. All individuals will be evaluated prior to treatment, after infusion weekly for four weeks, as well as at 8 weeks. |
| Phase Ib | EXPERIMENTAL | Administration of Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4: Subjects will receive four weekly infusions of the monoclonal anti-body at Dose Level 1 (0.5 mg/m2). If tolerated, the doses in the next patients will be increased to 5, 10, 50, 100, 250, and finally, 500 mg/m2. When the highest tolerated dose is reached without toxicity in 2 patients, an additional 4 patients will be enrolled and infused at that dose. Escalation or de-escalation will continue until we have determined the highest dose level at which less than 2 patients experience toxicity. All individuals will be evaluated prior to each course of treatment, as well as at weeks 5, 8, and 12. |
| Name | Type | Description |
|---|---|---|
| Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4 | DRUG | The antibody binds to the pathologic material and initiates a neutrophil/macrophage response |
Inclusion Criteria: * Patients must have a confirmed diagnosis of AL amyloidosis based on accepted clinical and laboratory criteria. * Patients are greater than 21 years old. * Female patients are not of child bearing potential or if they are of child bearing potential, they must not be pregnant...