Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
Amyloidosis
About this trial
This is an interventional treatment trial for Amyloidosis focused on measuring Amyloidosis, Relapse, Refractory
Eligibility Criteria
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 or breast-feeding.
- Patients have a life expectancy greater than 3 months.
- Patients have an Eastern Cooperative Oncology Group (ECOG)-specified performance status of less than or equal to 3.
- Patients to be included are those with measurable, localized amyloid deposits (larynx, subcutaneous tissue, muscle, lung, lymph nodes) or clinically evident systemic disease (liver, kidney, heart, etc).
- Only patients with prior systemic therapy with relapsed/refractory disease are eligible, unless they have declined or are not eligible for high-dose melphalan and autologous hematopoietic stem cell transplant (HSCT) or any other standard therapy that has been known to be life-prolonging or life-saving.
- Patients have adequate organ function.
- Patients with cancer are eligible provided they meet specific criteria.
- Patients must provide signed, written, informed consent and be willing and able to comply with eligibility requirements, scheduled, visits, and follow-up studies.
Exclusion Criteria:
- Non-AL amyloidosis.
- Renal failure (on dialysis).
- Females who are pregnant or breast-feeding.
- ECOG Performance Status greater than 3.
- Seriously limited cardiac, renal, or hepatic function.
- Uncontrolled infection or significant co-morbidity (e.g., uncontrolled diabetes, severe diarrhea).
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase Ia
Phase Ib
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.
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.