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Monoclonal Antibodies
Anti-CD38 Antibody Drug (STI-6129) for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By David Kaminetzky, 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
Eastern Cooperative Oncology Group (ECOG) performance of 0 - 2
Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments, including being refractory to a proteasome inhibitor, immunomodulatory agent and an anti-CD38 monoclonal antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion at up to approximately 24 months
Awards & highlights
Study Summary
This trial is testing a new drug for people with multiple myeloma who have relapsed or who are refractory to other treatments.
Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma who have tried other treatments, including a proteasome inhibitor and an anti-CD38 antibody. Participants must be in stable condition, able to perform daily activities (ECOG 0-2), and agree to use contraception. Excluded are those with significant heart issues, recent other cancers, severe infections like COVID-19 or hepatitis, certain blood disorders, or poor kidney function.Check my eligibility
What is being tested?
The study tests STI-6129, an experimental drug given intravenously every four weeks to people whose multiple myeloma has not responded to standard treatments. It's a phase 1b/2a trial that gradually increases the dose of STI-6129 to find the safest and most effective level for patients.See study design
What are the potential side effects?
Potential side effects of STI-6129 aren't detailed here but may include typical reactions related to immune therapies such as infusion-related symptoms (like fever or chills), fatigue, nausea, low blood counts increasing infection risk and possibly organ-specific inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
Select...
My multiple myeloma has returned or didn't respond to treatment including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion at up to approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion at up to approximately 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of STI-6129
Secondary outcome measures
Assess preliminary efficacy
Measuring Pharmacokinetic [PK] Profile
Overall response and duration
Trial Design
1Treatment groups
Experimental Treatment
Group I: STI-6129Experimental Treatment1 Intervention
Seven dosing cohorts will be evaluated: 0.67 mg/kg, 0.88 mg/kg, 1.18 mg/kg, 1.56 mg/kg, 2.08 mg/kg, 2.77 mg/kg, 3.68 mg/kg where STI-6129 will be intravenously administered once as part of a 4-week treatment cycle.
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Who is running the clinical trial?
Sorrento Therapeutics, Inc.Lead Sponsor
47 Previous Clinical Trials
1,952 Total Patients Enrolled
2 Trials studying Multiple Myeloma
64 Patients Enrolled for Multiple Myeloma
David Kaminetzky, MDPrincipal InvestigatorNYU Langone Health
Mike Royal, MDStudy DirectorSorrento Therapeutics, Inc.
27 Previous Clinical Trials
1,483 Total Patients Enrolled
1 Trials studying Multiple Myeloma
54 Patients Enrolled for Multiple Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any cancer drugs or experimental drugs within the last 4 weeks.I am able to care for myself and perform daily activities.Your oxygen level is at least 92% when measured with a pulse oximeter while breathing regular air.I had a stem cell transplant less than 6 months ago, have graft versus host disease, or am on immunosuppressive therapy post-transplant.I have HIV/AIDS or chronic hepatitis B or C.I have severe muscle weakness or serious eye problems.My blood clotting tests are abnormal, but I am on a stable dose of blood thinner.Your blood tests show low levels of hemoglobin, platelets, or neutrophils at the start of the study.You have a heart condition that is more severe than Class 2 according to the New York Heart Association classification.I have severe nerve pain or damage.Your heart's pumping ability is less than 40%.You have abnormal levels of certain proteins in your blood or bone marrow.Your lab test results for kidney function, liver enzymes, and bilirubin are not within normal range.Your heart's electrical activity is not normal on a specific heart test.I do not have any ongoing infections.I do not have an active COVID-19 infection or symptoms in the last 4 weeks.I have had cancer that needed treatment in the last 3 years or it's not fully in remission.My multiple myeloma has returned or didn't respond to treatment including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.I do not have any health or mental conditions that would stop me from joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: STI-6129
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for new participants in this research?
"This particular clinical trial, which was initially posted on December 1st 2022 and last edited on November 10th 2022, is still recruiting patients based off the information provided by clinicaltrials.gov"
Answered by AI
How many people are, at most, taking part in this experiment?
"That is correct. The listing on clinicaltrials.gov reveals that the trial, which was established on December 1st 2022, is recruiting patients. They need a total of 72 participants who will be located across 3 different hospitals or clinics."
Answered by AI
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