Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02245867
• Date of registration: 15/09/2014
• Prospective Registration: Yes
• Primary sponsor: Andrew Eisenberger
• Public title: Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
• Scientific title: Phase Ia/Ib Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
• Date of first enrolment: December 2, 2014
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02245867
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Andrew Eisenberger, MD
• Affiliation: CUMC

Key inclusion & exclusion 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).



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyloidosis

Intervention(s)

Drug: Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4

Primary Outcome(s)

Maximum Tolerated Dose (MTD) of Ch mAb 11-1F4 [Time Frame: 2 years approximately]

Secondary Outcome(s)

Number of subjects with positive amyloid-related organ response [Time Frame: 12 weeks]

Estimated mean area under the curve (AUC) for Ch mAb 11-1F4 [Time Frame: Phase 1a: 1, 2, 24 hours post start of infusion; then post-infusion week 1, 2, 3, 4, 8. Phase 1b: pretreatment, 1, 2, 24 hours post start of infusion; then post-infusion week 5, 8, 12.]

Number of participants with adverse events [Time Frame: 2 years approximately]

Secondary ID(s)

FDA Grant R01FD005110

AAAM5108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors