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Antibody-Drug Conjugate
STI-6129 for Amyloidosis
Phase 1 & 2
Recruiting
Led By Suzanne Lentzsch, MD
Research Sponsored by Sorrento Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0, 1, or 2
Females of childbearing potential (FCBP) must have 2 negative pregnancy tests prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective methods of birth control throughout the study
Must not have
Treatment with an allogeneic hematopoietic stem cell transplantation (HSCT) within 6 months prior to the planned infusion of STI-6129, or active graft-versus-host disease (GVHD) following the allogeneic transplant, or a requirement for currently receiving immunosuppressive therapy following the allogeneic transplant
Presence of non-AL amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion at up to 14 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is designed to find the best dose of STI-6129 to treat relapsed or refractory systemic AL amyloidosis while also assessing its safety and preliminary efficacy.
Who is the study for?
This trial is for adults with relapsed or refractory systemic AL amyloidosis who've had prior treatments. They must have measurable disease, be able to perform daily activities with minimal assistance (ECOG 0-2), and not be pregnant or breastfeeding. Participants should agree to use birth control and cannot have severe heart issues, certain infections like HIV/HBV/HCV, other recent cancers, or poor organ function.
What is being tested?
The study tests STI-6129, an antibody-drug conjugate targeting CD38 in patients with AL amyloidosis that has come back or didn't respond to treatment. It's a multi-stage trial aiming to find the safest and most effective dose by observing how well it works and how the body processes it.
What are the potential side effects?
Potential side effects of STI-6129 are not explicitly listed but may include reactions related to immune system activation against cancer cells, infusion-related responses, impact on blood counts and organ functions based on its mechanism as an antibody-drug conjugate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am capable of becoming pregnant and have had 2 negative pregnancy tests.
Select...
My diagnosis of AL amyloidosis was confirmed by a biopsy.
Select...
My AL amyloidosis has returned or didn't respond to treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a stem cell transplant from a donor within the last 6 months, have GVHD, or am on immunosuppressants after the transplant.
Select...
My condition is non-AL amyloidosis.
Select...
My amyloidosis is localized to my bone marrow, blood vessels, or a single area of soft tissue.
Select...
My AL amyloidosis is considered stage 4 or higher.
Select...
My heart's left ventricle wall is thick without high blood pressure or heart valve disease.
Select...
I have not had any infections 3 days before receiving STI-6129 treatment.
Select...
I have been diagnosed with multiple myeloma.
Select...
My heart condition limits my physical activity significantly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion at up to 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion at up to 14 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability of STI-6129 in AL amyloidosis patients
Secondary study objectives
Correlation of treatment response (organ responses and hematological response) with disease severity based on the 2012 revised Mayo Clinic staging system for AL amyloidosis
Organ response rates (cardiac, renal, hepatic, peripheral nervous system) according to the 2012 Consensus Round Table response criteria
Overall hematological response rate according to the 2012 Consensus Round Table response criteria
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: STI-6129 infusionExperimental Treatment1 Intervention
Intravenous infusion to be given with prophylaxis for infusion reactions if necessary.
Find a Location
Who is running the clinical trial?
Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,904 Total Patients Enrolled
1 Trials studying Amyloidosis
Suzanne Lentzsch, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
83 Total Patients Enrolled
Jeffrey Zonder, MDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute Wertz Clinic
2 Previous Clinical Trials
63 Total Patients Enrolled
1 Trials studying Amyloidosis
40 Patients Enrolled for Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.Your oxygen level is at least 92% when measured with a pulse oximeter while breathing room air.You have a specific type of measurable disease that can be detected through a blood test called serum-free light chain assay.Your heart is not pumping enough blood.Your blood tests show abnormal results before starting the study.I had a stem cell transplant from a donor within the last 6 months, have GVHD, or am on immunosuppressants after the transplant.I am capable of becoming pregnant and have had 2 negative pregnancy tests.My condition is non-AL amyloidosis.My amyloidosis is localized to my bone marrow, blood vessels, or a single area of soft tissue.My AL amyloidosis is considered stage 4 or higher.My diagnosis of AL amyloidosis was confirmed by a biopsy.Your blood test results are not normal before starting the study.My heart's left ventricle wall is thick without high blood pressure or heart valve disease.I haven't had any other cancers in the last 3 years, or if I have, they are in complete remission.My AL amyloidosis has returned or didn't respond to treatment.Your heart's electrical activity takes longer than usual to reset itself.I have not had any infections 3 days before receiving STI-6129 treatment.I have been diagnosed with multiple myeloma.I have HIV, HTLV1, HBV, or HCV, or am at risk for HBV reactivation.My heart condition limits my physical activity significantly.You have a specific protein in your blood called a monoclonal light chain.Your NT-proBNP level is higher than 1800 ng/L or your BNP level is higher than 400 ng/L.
Research Study Groups:
This trial has the following groups:- Group 1: STI-6129 infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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