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Monoclonal Antibodies
MT-0169 for Leukemia
Phase 1
Waitlist Available
Led By Abhishek Maiti, MBBS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients need to be ≥ 12 years of age
ECOG performance status of 0 to 2
Must not have
Patients with known symptomatic or uncontrolled CNS leukemia
Major surgery within 4 weeks prior to screening or a major wound that has not fully healed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if MT-0169 is safe for patients with AML or T-ALL, as well as study its effects. "This trial aims to determine if MT-0169 is
Who is the study for?
This trial is for patients with acute leukemia (AML or T-ALL) who have either not responded to previous treatments (relapsed/refractory) or still show signs of disease. Specific details on eligibility criteria are not provided.
What is being tested?
The safety and effects of a new drug called MT-0169 are being tested in this Phase I trial for individuals with CD38+ acute leukemia, specifically AML or T-ALL.
What are the potential side effects?
Potential side effects of MT-0169 are not listed, but common ones may include reactions at the injection site, fatigue, fever, nausea, and blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
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I can care for myself and am up and about more than 50% of my waking hours.
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I have been diagnosed with a specific type of leukemia.
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My condition has not improved or has worsened despite treatment.
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My first cancer remission lasted 12 months or less.
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My heart health meets the required standards.
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My leukemia cells show a high level of CD38.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have leukemia that is affecting my brain and is not under control.
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I have not had major surgery or unhealed major wounds in the last 4 weeks.
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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.
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I have an ongoing infection that hasn't improved with treatment.
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I have a heart condition.
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I have an active hepatitis B or C infection, or I am HIV positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Expansion Pediatrics: MT-0169Experimental Treatment1 Intervention
Group II: Expansion Adults: MT-0169Experimental Treatment1 Intervention
Group III: Escalation Pediatrics: MT-0169Experimental Treatment1 Intervention
Group IV: Escalation Adults: MT-0169Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,071 Previous Clinical Trials
1,803,203 Total Patients Enrolled
464 Trials studying Leukemia
31,795 Patients Enrolled for Leukemia
Abhishek Maiti, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
267 Total Patients Enrolled
3 Trials studying Leukemia
267 Patients Enrolled for Leukemia