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NCT02245867 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2025-02-07

The purpose of this study is to examine the tolerance, safety, pharmacokinetics, and possible clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive chimeric (Ch) IgG1 mAb 11-1F4 in patients with amyloid light-chain (AL) amyloidosis. The phase 1a part will involve at least 3 patients and a maximum of 18 patients. The first patient will receive the starting dose of the antibody and, if tolerated, the following patients will each receive (if tolerated) progressively higher doses of the antibody. Patients in part 1a of the trial will receive only one infusion of the drug. Patients treated in the phase 1a part receive lower dosage which might not be effective. Once the maximal tolerated dosage is established during the phase 1a part, the investigators will accrue patients to the phase 1b part of the trial. Patients will receive 4 infusions, once each week for 4 weeks. Patients who were treated in the part 1a of the trial and showed no toxicity can be also treated in the part 1b of the trial. The first patient will receive the starting dose of the antibody and, if tolerated, the following patients will each receive (if tolerated) progressively higher doses of the antibody. When the investigators reach the maximum tolerated dose without toxicity, the investigators will enroll another 4 patients to receive the same dose. If there are no toxicities, another 4 patients will be treated at the next dose level, and so forth. Patients treated in Phase 1b may receive lower dosages which might not be effective. The goal of Phase 1b is to establish the tolerance and possible beneficial effects of 11-1F4. If successful, treatment with this antibody would represent a novel approach in the care of individuals with AL amyloidosis.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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).
healthy Volunteers
false
minimum Age
21 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4
    label
    Phase Ia
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4
    label
    Phase Ib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase Ia
    2. Phase Ib
    description
    The antibody binds to the pathologic material and initiates a neutrophil/macrophage response
    name
    Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4
    other Names
    1. Ch mAb 11-1F4
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
30
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Maximum Tolerated Dose (MTD) of Ch mAb 11-1F4
    time Frame
    2 years approximately
secondary Outcomes
  1. description
    Amyloid-related organ response will be evaluated on the basis of the accepted criteria per consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis, in patients who completed phase 1b.
    measure
    Number of subjects with positive amyloid-related organ response
    time Frame
    12 weeks
  2. description
    This is designed to determine the pharmacokinetics of Ch mAb 11-1F4 when given as a single intravenous (i.v.) infusion (phase 1a) or as a series of four weekly intravenous infusions (phase 1b).
    measure
    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.
  3. description
    This to obtain additional safety data of Ch mAb 11-1F4 when given as a single intravenous infusion (phase 1a) or as a series of four weekly intravenous infusions (phase 1b) by obtaining adverse event information for all subjects during active follow-up visits.
    measure
    Number of participants with adverse events
    time Frame
    2 years approximately
Full study description
brief Summary
The purpose of this study is to examine the tolerance, safety, pharmacokinetics, and possible clinical benefit of the good manufacturing practice (GMP)-grade amyloid fibril-reactive chimeric (Ch) IgG1 mAb 11-1F4 in patients with amyloid light-chain (AL) amyloidosis. The phase 1a part will involve at least 3 patients and a maximum of 18 patients. The first patient will receive the starting dose of the antibody and, if tolerated, the following patients will each receive (if tolerated) progressively higher doses of the antibody. Patients in part 1a of the trial will receive only one infusion of the drug. Patients treated in the phase 1a part receive lower dosage which might not be effective. Once the maximal tolerated dosage is established during the phase 1a part, the investigators will accrue patients to the phase 1b part of the trial. Patients will receive 4 infusions, once each week for 4 weeks. Patients who were treated in the part 1a of the trial and showed no toxicity can be also treated in the part 1b of the trial. The first patient will receive the starting dose of the antibody and, if tolerated, the following patients will each receive (if tolerated) progressively higher doses of the antibody. When the investigators reach the maximum tolerated dose without toxicity, the investigators will enroll another 4 patients to receive the same dose. If there are no toxicities, another 4 patients will be treated at the next dose level, and so forth. Patients treated in Phase 1b may receive lower dosages which might not be effective. The goal of Phase 1b is to establish the tolerance and possible beneficial effects of 11-1F4. If successful, treatment with this antibody would represent a novel approach in the care of individuals with AL amyloidosis.
detailed Description
Presently, treatment of patients with amyloid light chain (AL) amyloidosis is limited to reducing production of the amyloid-forming light-chain protein by giving conventional or high-dose (with stem cell transplant) anti-plasma cell chemotherapy, as used for patients with multiple myeloma. Although this approach has extended survival, the prognosis remains poor due to the persistence or progression of the amyloid deposits in vital organs, such as the heart or kidney. A different treatment strategy would be to attempt to reduce and/or eliminate these deposits. This study evaluates this by administering an anti-amyloid monoclonal antibody, 11-1F4. This compound has been shown to reduce/destroy this material in an experimental animal model of amyloidosis.
Source references
references
  1. citation
    Solomon, A. and Weiss, D.T. Protein and host factors implicated in the pathogenesis of light chain amyloidosis (AL amyloidosis). Amyloid: Inter. J. Exper. Clin. Invest. 2: 269-279, 1995.
    type
    BACKGROUND
  2. citation
    Kyle RA, Gertz MA. Primary systemic amyloidosis: clinical and laboratory features in 474 cases. Semin Hematol. 1995 Jan;32(1):45-59. No abstract available.
    pmid
    7878478
    type
    BACKGROUND
  3. citation
    Merlini G, Bellotti V. Molecular mechanisms of amyloidosis. N Engl J Med. 2003 Aug 7;349(6):583-96. doi: 10.1056/NEJMra023144. No abstract available.
    pmid
    12904524
    type
    BACKGROUND
  4. citation
    Kyle RA, Gertz MA, Greipp PR, Witzig TE, Lust JA, Lacy MQ, Therneau TM. A trial of three regimens for primary amyloidosis: colchicine alone, melphalan and prednisone, and melphalan, prednisone, and colchicine. N Engl J Med. 1997 Apr 24;336(17):1202-7. doi: 10.1056/NEJM199704243361702.
    pmid
    9110907
    type
    BACKGROUND
  5. citation
    Palladini G, Anesi E, Perfetti V, Obici L, Invernizzi R, Balduini C, Ascari E, Merlini G. A modified high-dose dexamethasone regimen for primary systemic (AL) amyloidosis. Br J Haematol. 2001 Jun;113(4):1044-6. doi: 10.1046/j.1365-2141.2001.02859.x.
    pmid
    11442500
    type
    BACKGROUND
  6. citation
    Comenzo RL, Gertz MA. Autologous stem cell transplantation for primary systemic amyloidosis. Blood. 2002 Jun 15;99(12):4276-82. doi: 10.1182/blood.v99.12.4276.
    pmid
    12036853
    type
    BACKGROUND
  7. citation
    Skinner M, Sanchorawala V, Seldin DC, Dember LM, Falk RH, Berk JL, Anderson JJ, O'Hara C, Finn KT, Libbey CA, Wiesman J, Quillen K, Swan N, Wright DG. High-dose melphalan and autologous stem-cell transplantation in patients with AL amyloidosis: an 8-year study. Ann Intern Med. 2004 Jan 20;140(2):85-93. doi: 10.7326/0003-4819-140-2-200401200-00008.
    pmid
    14734330
    type
    BACKGROUND
  8. citation
    Landau H, Hassoun H, Rosenzweig MA, Maurer M, Liu J, Flombaum C, Bello C, Hoover E, Riedel E, Giralt S, Comenzo RL. Bortezomib and dexamethasone consolidation following risk-adapted melphalan and stem cell transplantation for patients with newly diagnosed light-chain amyloidosis. Leukemia. 2013 Apr;27(4):823-8. doi: 10.1038/leu.2012.274. Epub 2012 Sep 27.
    pmid
    23014566
    type
    BACKGROUND
  9. citation
    O'Nuallain B, Allen A, Kennel SJ, Weiss DT, Solomon A, Wall JS. Localization of a conformational epitope common to non-native and fibrillar immunoglobulin light chains. Biochemistry. 2007 Feb 6;46(5):1240-7. doi: 10.1021/bi0616605.
    pmid
    17260953
    type
    BACKGROUND
  10. citation
    O'Nuallain B, Allen A, Ataman D, Weiss DT, Solomon A, Wall JS. Phage display and peptide mapping of an immunoglobulin light chain fibril-related conformational epitope. Biochemistry. 2007 Nov 13;46(45):13049-58. doi: 10.1021/bi701255m. Epub 2007 Oct 18.
    pmid
    17944486
    type
    BACKGROUND
  11. citation
    Hrncic R, Wall J, Wolfenbarger DA, Murphy CL, Schell M, Weiss DT, Solomon A. Antibody-mediated resolution of light chain-associated amyloid deposits. Am J Pathol. 2000 Oct;157(4):1239-46. doi: 10.1016/S0002-9440(10)64639-1.
    pmid
    11021828
    type
    BACKGROUND
  12. citation
    Solomon A, Weiss DT, Wall JS. Immunotherapy in systemic primary (AL) amyloidosis using amyloid-reactive monoclonal antibodies. Cancer Biother Radiopharm. 2003 Dec;18(6):853-60. doi: 10.1089/108497803322702824.
    pmid
    14969598
    type
    BACKGROUND
Source notices and limitations
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        id in an effort to promote phagocytosis and clearance of the amyloid deposits.</p> <div class="pdq-content-list"><ol id="_1150"><li>In a phase I study (NCT02245867), 27 patients with deep hematologic responses to myeloma therapy, but persistent organ involvement, received anselamimab.[<a href="#cit/section_4.35">35</a>]<d
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      1. context
        Updated: April 25, 2025
        datetime
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        display
        April 25, 2025

    Preserved source evidence · Not medical advice