Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/13/2018 |
| Start Date: | December 2, 2014 |
| End Date: | July 23, 2017 |
Phase Ia/Ib Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL Amyloidosis
The purpose of this study is to examine the tolerance, safety, pharmakinetics, 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 e 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.
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 e 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.
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.
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.
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).
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Suzanne Lentzsch, MD, PhD
Phone: 347-344-8948
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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