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Also known as Ch mAb 11-1F4
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...
Top 10 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 8 | PHASE3 | CAEL-101, AZD0120, GC012F |
| Intellia Therapeutics, Inc. | NTLA | 1 | PHASE3 | Nexiguran ziclumeran |
| Immix Biopharma, Inc. | IMMX | 2 | PHASE3 | NXC-201 |
| Johnson & Johnson | JNJ | 3 | PHASE2 | Daratumumab, Bortezomib, Teclistamab, JNJ-79635322 |
| BridgeBio Pharma, Inc. | BBIO | 2 | PHASE3 | Acoramidis |
| GSK plc Sponsored ADR | GSK | 1 | PHASE2 | Belantamab mafodotin |
| Alnylam Pharmaceuticals, Inc | ALNY | 4 | EARLY_PHASE1 | patisiran |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Isatuximab |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-383 |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | linvoseltamab |
Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4 is an investigational therapy being developed by AstraZeneca PLC for AL Amyloidosis, a rare disease. It is in Phase 1 clinical development and has been studied in a single completed clinical trial. It is not an approved treatment.
Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4 is being studied for the treatment of AL Amyloidosis, a rare disease in which abnormal amyloid fibrils accumulate in organs. Its only recorded clinical trial enrolled patients with AL Amyloidosis. The drug remains investigational and is not approved for any use.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4. The company is studying the agent in AL Amyloidosis through its clinical development program.
Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for AL Amyloidosis or any other indication.
Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4 has been evaluated in one completed Phase 1 trial, NCT02245867, titled Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis. The trial enrolled 30 patients in the United States, included adults 21 years and older, and used a controlled design.