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Engineered Toxin Body
MT-0169 for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing MT-0169, an investigational drug that recognizes and binds to the CD38 receptor on cancer cells, delivering a modified toxin that kills the cells.
Who is the study for?
This trial is for adults with Multiple Myeloma that has come back or hasn't responded to treatment. They should have tried other treatments without success, be relatively healthy and active (ECOG score of 0 or 1), and not have certain heart conditions or allergies related to the study drug. Women must not be pregnant, and all participants must agree to use effective birth control.Check my eligibility
What is being tested?
The trial is testing MT-0169, a new type of therapy targeting CD38 on cancer cells in patients with relapsed/refractory multiple myeloma. It's an early-phase study where doses are increased gradually to find the safest dose that can effectively kill cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions similar to those from antibiotics like kanamycin since MT-0169 is related to this drug class. There may also be general side effects such as fatigue, allergic reactions, and potential organ inflammation due to its toxin component.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Number of participants who discontinued MT-0169 due to TEAEs
Number of participants with Dose-limiting Toxicities (DLTs)
+4 moreSecondary outcome measures
AUClast: Area Under the Concentration-time Curve From Time 0 to the time of the last quantifiable concentration for MT-0169
Clinical Benefit Rate (CBR) for RRMM patients
Cmax: maximum observed concentration for MT-0169
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Part 1: Dose EscalationExperimental Treatment1 Intervention
Weekly Dosing Intravenous (IV) infusion of MT-0169 every 7 days: Days 1, 8, 15, and 22 in a 28-day treatment cycle.
Every 2 Weeks IV infusion of MT-0169 every 14 days: Days 1 and 15 in a 28-day treatment cycle with escalating doses starting at the MTD/RP2D determined by the weekly dose escalation cohort.
Patients will continue to receive treatment until progressive disease, unacceptable toxicity or withdraw from the study for other reasons. Decision to escalate/deescalate/stay on the same dose/discontinue MT-0169 will be based on number of DLTs per number of patients enrolled at each dose level as predetermined by the mTPI-2 statistical model. Subsequent doses will be determined by the frequency and severity of adverse events in previous cohorts. The investigator and sponsor review of available safety, PK, pharmacodynamics, and efficacy data in the previous cohorts will also be factored in the decision.
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Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,248 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,219 Patients Enrolled for Multiple Myeloma
Molecular Templates, Inc.Lead Sponsor
9 Previous Clinical Trials
443 Total Patients Enrolled
Medical DirectorStudy DirectorTakeda
2,777 Previous Clinical Trials
8,063,850 Total Patients Enrolled
25 Trials studying Multiple Myeloma
6,984 Patients Enrolled for Multiple Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had myelodysplastic syndrome or another type of cancer, except for certain exceptions.You have amyloidosis in any organ, or amyloid on the bone marrow biopsy without other signs of amyloidosis.If you have any of these heart problems.You have multiple myeloma and have not responded well to or cannot tolerate the currently available treatments that have shown to be effective.You have not fully recovered from side effects of previous treatments, except for hair loss and stable mild nerve pain.You have been diagnosed with multiple myeloma using specific diagnostic criteria.You have a disease that can be measured.You have a performance score of 0 or 1 according to the Eastern Cooperative Oncology Group.This criterion refers to specific cardiovascular measurements or indicators that will be used to determine eligibility for the clinical trial. The details of the parameters would need to be specified to provide a clear explanation.It looks like the criterion is incomplete. Could you please provide more details or the complete criterion for me to rewrite it in a simplified form?You have certain blood and nerve-related conditions like POEMS syndrome, amyloidosis, or Waldenström macroglobulinemia.You have received a live vaccine within 28 days before the first dose of MT-0169.You have had serious fluid build-up around your lungs or heart in the past 3 months.You have a long-lasting or current infection that needs medication, or you had a serious viral infection that hasn't completely healed.You have a type of cancer called RRMM and have not responded well to standard treatments or cannot tolerate them.You have had a transplant using stem cells or an organ from someone else.You have a long-term condition that requires taking more than 10mg of prednisone or an equivalent medication every day.You have had a bad reaction to kanamycin or similar medications in the past.You have been diagnosed with multiple myeloma based on specific criteria.Your blood or urine tests don't show the specific protein levels needed for the study, especially if you have the disease in other parts of your body.You have a disease that can be measured.You have severe nerve problems causing issues with feeling or movement.You have not fully recovered from side effects of past myeloma treatments or procedures, except for hair loss and mild nerve problems.You have symptoms that show your central nervous system is involved in the disease.You have a medical or mental illness that would make it hard for you to take part in the study or be evaluated, such as uncontrolled medical conditions, active infection, or serious liver or lung diseases.You have had a serious inflammatory reaction after receiving certain types of antibody or CAR T therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Escalation
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.
How many participants have signed up for the experiment?
"Affirmative. As indicated on clinicaltrials.gov, the trial that was initially posted back in February 5th 2020 is actively seeking applicants. This research requires 144 patients to be recruited across 7 sites."
Answered by AI
How have patients reacted to the MT-0169 drug regimen?
"MT-0169's safety is rated as a 1, due to the fact that it is still in Phase 1 and has yet to have sufficient efficacy or safety data collected."
Answered by AI
Is this research endeavor actively recruiting participants?
"Per the clinicaltrials.gov website, this trial is currently recruiting participants and was initially posted on February 5th 2020 with a most recent edit on September 6th 2022."
Answered by AI
How many sites are currently overseeing this clinical experiment?
"Currently, seven medical centres are recruiting participants for this study. These institutions include Miami University in Miami, Northside Hospital in Atlanta and Indiana University in Indianapolis."
Answered by AI
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